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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.

2021

JP | Mochida and Ayumi launch 100mg/mL adalimumab biosimilar in Japan

November 25, 2021

Mochida Pharmaceutical and Ayumi Pharmaceutical announced the launch of high-dose 100mg/mL Adalimumab BS MA (adalimumab biosimilar) in Japan.

New study of belimumab after rituximab in SLE demonstrates promising results

November 24, 2021

A new study of belimumab after rituximab reported a reduction of serum IgG anti-double-stranded DNA antibody levels and the risk for severe flare in systemic lupus erythematosus refractory in comparison to conventional therapy.

Dong-A ST completes patient enrolment for Ph III trials of DMB-3115 (proposed denosumab biosimilar)

November 22, 2021

Korea Biomedical Review reported that Dong-A ST has completed patient enrolment for Ph III trials of DMB-3115 (proposed denosumab biosimilar) in patients with moderate to severe chronic plaque psoriasis.

Innovent releases the results of Ph III studies of sintilimab and BYVASDA® (bevacizumab biosimilar) combined with chemotherapy in lung cancer

November 21, 2021

Innovent released the results of a Ph III study of sintilimab and BYVASDA® (bevacizumab biosimilar) combined with chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung cancer who progressed after EGFT-TKI therapy.

Merck completes cash tender offer for all of the outstanding shares of common stock of Acceleron Pharma

November 19, 2021

Merck announced that it has successfully completed the cash tender offer for all of the outstanding shares of common stock of Acceleron Pharma through its subsidiary Astros Merger Sub, Inc.  Merck announced that it intends to complete the acquisition through a merger of Astros Merger Sub with and into Acceleron, with Acceleron being the surviving corporation.

US | Samsung Bioepis publishes new biosimilars white paper

November 17, 2021

Samsung Bioepis launched a new white paper entitled ‘Improving the Understanding and Acceptance of Biosimilars in the United States’. In particular, the paper discusses the need to reduce information gaps, incentivise different stakeholders and practical considerations for implementation.

NZ | NZ’s Pharmac to transfer Principal Supply status to Amgevita® (biosimilar adalimumab)

November 17, 2021

Pharmac announced that it will transfer Principal Supply status from Humira® (adalimumab) to Amgevita® (biosimilar adalimumab) from 01 March 2022.

US | Viatris and Biocon launch Semglee® (interchangeable biosimilar insulin glargine) in the US

November 16, 2021

Viatris and Biocon announced the US launch of Semglee® (interchangeable biosimilar insulin glargine) and Insulin Glargine.

EU | EC approves Regkirona® (regdanvimab, CT-P59) for adults with COVID-19

November 15, 2021

Celltrion announced that the EC has approved Regkirona® (regdanvimab, CT-P59) for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

AU | AU’s PBAC publishes the outcomes from its July 2021 meeting

November 12, 2021

AU’s PBAC published the outcomes from its July 2021 meeting. PBAC recommended listing:

  • Pfizer’s Abrilada® (50mg/mL adalimumab biosimilar) in 20mg/0.4mL syringe, 40mg/0.8mL syringe and 40mg/0.8mL pen for all indications as Humira®.
  • Janssen’s Darzalex SC® (daratumumab) for all indications for which the intravenous form of daratumumab is currently listed.
  • Pfizer’s Enbrel® (etanercept) in 50mg/1mL single use dose-dispenser cartridges under the same conditions as existing listings for etanercept.
  • BMS’ Opdivo® (nivolumab) for the treatment of patients with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression following treatment with a fluoropyrimidine and platinum (FP)-based chemotherapy regimen.

RegenXBio announces additional interim data from Ph II trials of RGX-314

November 12, 2021

RegenXBio announced additional interim data from its Ph II trials of RGX-314 (proposed one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases). RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein.

EU | CHMP recommends Celltrion’s Regkirona® regdanvimab for COVID-19

November 12, 2021

The CHMP recommended approval of Celltrion’s Regkirona® regdanvimab for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

Celltrion provides update on biosimilars pipeline

November 10, 2021

Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.

FDA review of CHS-201 (proposed adalimumab biosimilar) advancing towards the target action date in December 2021

November 9, 2021

Coherus BioSciences reported its Q3 2021 financial results. Coherus announced that FDA review of CHS-201 (proposed adalimumab biosimilar) is advancing towards the target action date in December 2021. Coherus also disclosed that the FDA has accepted the BLA for its proposed toripalimab biosimilar for advanced nasopharyngeal carcinoma, with a target action date of April 2022.

Novartis to sell stake in Roche

November 4, 2021

Novartis announced that it will sell its stake in Roche for a total of USD 20.7 billion, stating that it no longer views its financial stake in Roche as part of its core business. This follows the announcement by Novartis that it would undertake a strategic review of the Sandoz division.

US | Prime Therapeutics adds Semglee® (interchangeable biosimilar insulin glargine) to its preferred national formularies

November 3, 2021

Pharmacy benefit manager Prime Therapeutics announced that it will add Semglee® (interchangeable biosimilar insulin glargine) to its preferred national formularies.

EU | Fresenius Kabi expecting to launch pegfilgrastim biosimilar in the EU in 2022

November 2, 2021

Fresenius Kabi released its Q3 2021 financial results. Fresenius Kabi confirmed that despite delays due to COVID-19, it expects to launch its pegfilgrastim biosimilar candidate in the EU in 2022.

Pfizer to launch citrate-free adalimumab in the US as early as 1 July 2023

November 2, 2021

Pfizer released its Q3 2021 results, reporting a 34% increase operationally in biosimilars. Pfizer announced that it plans to launch citrate-free Abrilada® (biosimilar adalimumab) in the US as early as 1 July 2023 in accordance with its agreement with AbbVie. Pfizer disclosed that it plans to seek interchangeable status for Abrilada® in December 2021.

IGBA calls on stakeholders ahead of Global Biosimilars Week

November 1, 2021

The International Generic and Biosimilar Medicines Association called on all stakeholders ahead of its second Global Biosimilars Week to join the Biosimilars Movement on Advancing Access. The campaign seeks to gather useful ideas, experience, information and resources for and from patients, doctors and all other stakeholders across the healthcare community.

Teva releases its Q3 2021 financial results

October 27, 2021

Teva released its Q3 2021 financial results, reporting a 2% decrease in revenues compared to Q3 2020. Teva disclosed that it does not expect to launch any new biosimilars in 2022.

Samsung Bioepis completes Ph III trials of SB12 (proposed eculizumab biosimilar) for the treatment of paroxysmal nocturnal hemoglobinuria

October 27, 2021

Korea Biomedical Review announced that Samsung Bioepis has completed Ph III trials of SB12 (proposed eculizumab biosimilar) for the treatment of paroxysmal nocturnal hemoglobinuria.

Novartis to conduct strategic review of Sandoz division

October 26, 2021

Novartis disclosed in its Q3 2021 earnings announcement that it will undertake a strategic review of the Sandoz division. Novartis stated that this review will explore all options ranging from retaining the business to separation.

Janssen announced data from two new analyses of the use of Stelara® (ustekinumab) in Crohn’s disease and ulcerative colitis

October 25, 2021

Janssen announced data from two new analyses of Stelara® (ustekinumab) for the treatment of adults with Crohn’s disease and ulcerative colitis. Janssen reported that the data from these analyses provides additional support for Stelara® as a first-line option for Crohn’s disease and ulcerative colitis.

JP | Chugai Pharma to construct a new manufacturing facility in Tokyo

October 22, 2021

Chugai Pharmaceutical announced that it will construct a new manufacturing facility in Tokyo to produce biopharmaceuticals for early clinical trials.

Biocon reports 10% increase in biosimilars revenue year on year

October 22, 2021

Biocon released its Q2 2022 financial results, reporting a 10% increase in biosimilars revenue year on year.

US | FDA approves Susvimo™ (ranibizumab) for intravitreal use via ocular implant for the treatment of wet age-related macular degeneration

October 22, 2021

Genentech announced that the FDA has approved Susvimo™ (ranibizumab) for intravitreal use via ocular implant for the treatment of patients with wet age-related macular degeneration who have previously responded to at least two anti-VEGF injections.

EU | EMA approves Opdivo® (nivolumab) for the first-line treatment of gastric, gastroesophageal junction or esophageal adenocarcinoma

October 21, 2021

BMS announced that the EMA has approved Opdivo® (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

CN | China’s NMPA approves clinical trials for GT90008 (PD-L1/TGF-β dual-targeting antibody)

October 21, 2021

Kintor Pharmaceutical announced that China’s NMPA has approved clinical trials for GT90008 (PD-L1/TGF-β dual-targeting antibody) for the treatment of advanced solid tumours.

AU | NSW State Government pledges $96 million towards a RNA pilot manufacturing facility

October 21, 2021

The NSW State Government pledged $96 million towards a RNA pilot manufacturing facility, to be established in partnership with NSW universities. The facility is expected to house laboratories and pre-clinical trial spaces to enable early-stage RNA-based drug development.

US | Semglee® (interchangeable biosimilar insulin glargine) listed as a preferred insulin brand on National Preferred Formulary

October 21, 2021

Biocon announced that pharmacy benefit management company Express Scripts will list Semglee® (interchangeable biosimilar insulin glargine) as a preferred insulin brand on its National Preferred Formulary.

First patient dosed in Ph II trials evaluating felzartamab for patients with Immunoglobulin A Nephropathy

October 20, 2021

MorphoSys announced that the first patient has been dosed in its Ph II trials evaluating felzartamab for patients with Immunoglobulin A Nephropathy.

HepaRegeniX and the Netherlands Cancer Institute announce collaboration on HRX-0233 (MKK4 inhibitor candidate)

October 20, 2021

HepaRegeniX announced a new collaboration with the Netherlands Cancer Institute to investigate HRX-0233 (MKK4 inhibitor candidate) in preclinical in vivo models with Kirsten rat sarcoma virus (KRAS) mutant tumours.

Clinical trial sites in the Asia-Pacific open for patient enrolment in Opthea’s Ph III trials of OPT-302

October 19, 2021

Opthea announced that the first clinical trial sites in the Asia-Pacific region are now open for patient enrolment in its Ph III trials of OPT-302 (VEGF-C/-D ‘trap’ inhibitor).

AU | Australia’s TGA provisionally approves Roche’s Ronapreve™ (casirivimab and imdevimab) for two indications relating to COVID-19

October 18, 2021

Australia’s TGA provisionally approved Roche’s Ronapreve™ (casirivimab and imdevimab) for two indications relating to COVID-19. Ronapreve™ is indicated for the treatment of COVID-19 in adults and adolescents who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19, and for the prevention of COVID-19 in adults and adolescents who have been exposed to SARS-CoV-2 and who either have a medical condition making them unlikely to respond to or to be protected by vaccination or are not vaccinated against COVID-19.

Bio-Thera Solutions and Pharmapark reach deal for ustekinumab biosimilar

October 16, 2021

Bio-Thera Solutions announced it has reached a licensing and supply agreement with Pharmapark for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Pharmapark will have exclusive rights to distribute and market the product in Russia and other CIS countries.

EU | CHMP recommends approving Keytruda® (pembrolizumab) plus Lenvima®/Kisplyz® (lenvatinib) for renal cell cancer and endometrial carcinoma

October 15, 2021

Merck and Eisai announced that the CHMP has adopted positive opinions recommending the approval of the combination of Keytruda® (pembrolizumab) plus Lenvima®/Kisplyz® (lenvatinib) for the first-line treatment of adults with advanced renal cell cancer and for the treatment of adults with advanced or recurrent endometrial carcinoma.

US | FDA approves Cyltezo® (biosimilar adalimumab) as the first biosimilar designated as interchangeable with Humira® (adalimumab)

October 15, 2021

Boehringer Ingelheim announced that FDA has approved Cyltezo® (biosimilar adalimumab) as the first biosimilar designated as interchangeable with Humira® (adalimumab).   Cyltezo® is a 50 mg/mL “citrate free” (ie acetate buffered) product, and the “interchangeable” designation will be limited to only some of the Humira® products, unless FDA responds favourably to the citizen petition lodged by Boehringer Ingelheim in December 2020 requesting FDA to interpret the term “strength” in legislation in section 351(k) of the Public Health Service Act (42 U.S.C. 262(k) in a manner which would extend BI’s interchangeability designation to all formulations delivering the same amount of active (irrespective of concentration).  The FDA stated in a May 2021 interim response that it has been unable to made a decision on the CP to date “because it raises complex issues requiring extensive review and analysis by Agency officials”.

FDA approves Tecentriq® (atezolizumab) as adjuvant treatment for adults with Stage II-IIIA non-small cell lung cancer

October 15, 2021

Roche announced that the FDA has approved Tecentriq® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer whose tumours express PD-L1≥1%.

Gan & Lee Pharmaceuticals complete Ph III trials of proposed insulin glargine

October 14, 2021

Gan & Lee Pharmaceuticals announced the completion of two Ph III studies of its proposed insulin glargine biosimilar.

US | FDA approves Keytruda® (pembrolizumab) plus chemotherapy, with or without bevacizumab for cervical cancer

October 13, 2021

Merck announced that the FDA has approved Keytruda® (pembrolizumab) plus chemotherapy, with or without bevacizumab, as a treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1.

EU | Celltrion submits MAA to EMA for biosimilar bevacizumab

October 12, 2021

The Korea Herald announced that Celltrion has submitted a Marketing Authorisation Application to the EMA for CT-P16 (proposed bevacizumab biosimilar).

AU | Australian pharmacists raise concerns over proforma letters provided by AbbVie

October 9, 2021

The Australian reported that Australian pharmacists have raised concerns over proforma letters provided by AbbVie to prescribing doctors (specialist rheumatologists and gastroenterologists) and public hospital clinics instructing chemists to only dispense Humira® branded adalimumab rather than biosimilar adalimumab.

US | Aggregate savings enabled by biosimilars 4.3 times higher than that of generics

October 8, 2021

A new study published in Stat News reported that the aggregate savings enabled by biosimilars in the US was 4.3 times higher than that of generics.

US | Janssen submits sBLA for Stelara® (ustekinumab

October 8, 2021

Janssen announced the submission of a sBLA to the FDA seeking expanded approval of Stelara® (ustekinumab) to treat paediatric patients aged 5 years and older with juvenile psoriatic arthritis.

AU | AU’s TGA approves Enhurtu® (trastuzumab deruxtecan)

October 8, 2021

Australia’s TGA approved AstraZeneca’s Enhurtu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.

US | US District Court dismisses Humira® trade secrets lawsuit brought by AbbVie against Alvotech

October 8, 2021

The US District Court for the Northern District of Illinois dismissed the Humira® trade secrets lawsuit brought by AbbVie against Alvotech for lack of jurisdiction.

Xbrane Biopharma and AGC Biologics enters into agreement for Xcimzane™ (certolizumab pegol)

October 7, 2021

Xbrane Biopharma and AGC Biologics entered into an agreement to manufacture Xcimzane™ (certolizumab pegol) for clinical development.

EU | Celltrion submits MAA to EMA for regdanvimab

October 5, 2021

Celltrion announced that it has submitted a Marketing Authorisation Application to the EMA seeking approval of regdanvimab for the treatment of COVID-19 in adults who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19.

Coherus Biosciences announces positive results from study of Udencya® (biosimilar pegfilgrastim) administered via an on-body injector device

October 5, 2021

Coherus Biosciences announced positive results from a randomised, open-label, crossover study assessing the pharmacokinetic and pharmacodynamic bioequivalence of Udencya® (biosimilar pegfilgrastim) administered via an on-body injector device compared to the currently marketed Udencya® pre-filled syringe. Coherus plans to submit its application to the FDA in 2022 and expects to launch directly post approval.

Enrolment in OPT-302 trials opens in Europe

October 4, 2021

Opthea announced the enrolment for its Ph III trials of OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in the treatment of wet (neovascular) age-related macular degeneration has opened in Europe.

Celltrion presents new data on Remsima® SC (biosimilar infliximab)

October 3, 2021

Celltrion presented two new data sets on the use of Remsima® SC (biosimilar infliximab) in inflammatory bowel disease in a poster presentation at United European Gastroenterology Week 2021.

New study reports on Boan Biotechnology’s LY01008 (proposed bevacizumab biosimilar)

October 2, 2021

A new study published in Cancer Communications reported that Boan Biotechnology’s LY01008 (proposed bevacizumab biosimilar) demonstrated similarity to Avastin® in patients with advanced or recurrent non-squamous NSCLC.

US | FDA accepts for review the BLA for CHS-201 (proposed biosimilar ranibizumab)

October 1, 2021

Coherus Biosciences announced that the FDA has accepted for review the BLA for CHS-201 (proposed biosimilar ranibizumab).

KR | US | Celltrion submits application for CT-P16 (proposed biosimilar bevacizumab) in the US and Korea

October 1, 2021

Korea Biomedical Review reported that Celltrion has submitted an application for CT-P16 (proposed biosimilar bevacizumab) in the US and Korea.

EU | MAA for Xlucane™ (proposed biosimilar ranibizumab) submitted to the EMA

September 30, 2021

Xbrane Pharma and STADA announced that the MAA for Xlucane™ (proposed biosimilar ranibizumab) has been submitted to the EMA.

US | US House Judiciary Committee votes in favour of the Preserve Access to Affordable Generics and Biosimilars Act

September 29, 2021

The US House Judiciary Committee voted in favour of the Preserve Access to Affordable Generics and Biosimilars Act. If passed, this act would allow the FTC to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connected with the sale of a drug or biological product.

US | FDA approves Erbitux® (cetuximab) in combination with Braftovi® (encorafenib) for metastatic colorectal cancer

September 28, 2021

Eli Lilly announced that the FDA has approved Erbitux® (cetuximab) in combination with Braftovi® (encorafenib) for the treatment of metastatic colorectal cancer with a BRAF V600E mutation.

CA | Health Canada has approved Bambevi® (biosimilar bevacizumab)

September 27, 2021

Apobiologix announced that Health Canada has approved Bambevi® (biosimilar bevacizumab) in combination with chemotherapy to treat specific types of colorectal, lung, brain and ovarian cancer.

New study indicates live virus Varicella-Zoster vaccine in immunosuppressed patients receiving biologic therapies may be a reasonable option

September 27, 2021

A new study published in Annals of Internal Medicine reported that a live virus Varicella-Zoster vaccine in immunosuppressed patients receiving biologic therapies may be a reasonable option if no alternative vaccine is available.

JP | Humira® receives additional approvals for high-dose regimen in Japan

September 27, 2021

AbbVie, Eisai Co and EA Pharma announced Humira® (adalimumab) has received additional approvals in Japan for its high-dose regimen in adults with ulcerative colitis and in a new regimen in paediatric patients.

CN | NMPA approves IND for BCMA-targeted Chimeric Antigen Receptor (CAR) T cell

September 27, 2021

JW Therapeutics announced that China’s NMPA has approved the IND for a clinical trial of BCMA-targeted Chimeric Antigen Receptor (CAR) T cell JWCAR129 in treating relapsed or refractory multiple myeloma.

Hikma Pharmaceuticals to acquire Custopharm

September 27, 2021

Hikma Pharmaceuticals announced that it will acquire Custopharm for an initial cash consideration of USD $375 million with a further USD $50 million in contingent consideration payable upon the achievement of certain commercial milestones.

PharmGene Science and Access Bio enter into MOU for biosimilar mRNA COVID-19 vaccine

September 23, 2021

PharmGene Science and Access Bio announced that they have signed a Memorandum of Understanding for the joint development and commercialisation of a biosimilar mRNA COVID-19 vaccine.

EU | CuraTeQ submits MAA to EMA for proposed biosimilar pegfilgrastim

September 23, 2021

Business Standard reported that Aurobindo Pharma (through the subsidiary CuraTeQ Biologics) has submitted a Marketing Authorisation Application to the EMA for BP14 (proposed biosimilar pegfilgrastim).

180 Life Sciences and Celltrion enter into MOU for anti-TNF biosimilars

September 20, 2021

180 Life Sciences and Celltrion announced that they have entered into a Memorandum of Understanding for the supply of an anti-TNF biosimilar drug to be used for new indications with significant unmet medical needs.

US | AbbVie submits regulatory application for Skyrizi® (risankizumab) to the FDA for the treatment of Crohn’s Disease

September 20, 2021

AbbVie announced it has submitted the regulatory application for Skyrizi® (risankizumab) to the FDA for the treatment of patients 16 years and older with moderate to severe Crohn’s Disease.

US | FDA approves Byooviz® (biosimilar ranibizumab)

September 20, 2021

Samsung Bioepis and Biogen announced that the FDA has approved Byooviz® (biosimilar ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, macular edema and myopic choroidal neovascularisation.

Henlius to present new studies on serplulimab (anti-PD-1 mAb) and HLX04 (bevacizumab biosimilar)

September 18, 2021

Henlius announced that it will present the results of new studies on serplulimab (anti-PD-1 mAb) and HLX04 (bevacizumab biosimilar) at the 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO).

KR | South Korea’s MFDS approves Celltrion’s regdanvimab for COVID-19

September 18, 2021

Celltrion announced that South Korea’s MFDS has approved regdanvimab for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition with mild symptoms of COVID-19, and in adults patients with moderate symptoms of COVID-19.

Merck releases new data on Keytruda® (pembrolizumab) in resected stage II melanoma

September 18, 2021

Merck announced that the first results from Ph III trials of Keytruda® (pembrolizumab) showed a statistically significant and clinically meaningful improvement in recurrence-free survival compared to placebo in patients with resected high-risk stage II melanoma.

EU | EU’s CHMP recommends the approval of AVT02 (proposed adalimumab biosimilar)

September 17, 2021

Alvotech announced that the EU’s CHMP has adopted a positive opinion recommending the approval of AVT02 (proposed adalimumab biosimilar).

AbbVie and REGENXBIO announce new partnership to develop and commercialise RGX-314

September 13, 2021

AbbVie and RegenXBio announced a partnership to develop and commercialise RGX-314 (proposed one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases).

Samsung Bioepis releases new data on five-year follow-up study of Ontruzant® (trastuzumab biosimilar)

September 13, 2021

Samsung Bioepis reported on a five-year follow-up study comparing ONTRUZANT® (trastuzumab biosimilar) with reference trastuzumab in early or locally advanced HER2 positive breast cancer. Samsung Bioepis reported that five year survival rates were 93.1% in the biosimilar trastuzumab group compared with 86.7% in the reference medicine group.

AU | Australia’s TGA approves Kyowa Kirin’s Crysvita® (burosumab)

September 10, 2021

Australia’s TGA approved Kyowa Kirin’s Crysvita® (burosumab) for the treatment of X-linked hypophosphataemia.

Alvotech announces positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®

September 10, 2021

Alvotech announced positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®. Alvotech reported that no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference cohort.

BioFactura and Rani Therapeutics enter into agreement relating to proposed ustekinumab biosimilar

September 9, 2021

BioFactura announced it has reached an agreement with Rani Therapeutics to assess BFI-751 (proposed ustekinumab biosimilar) in combination with the RaniPill® platform. The RaniPill® capsule is intended to replace subcutaneous or IV injection of biologics with oral dosing.

Samsung Bioepis announces new data from Ph III clinical study of Byooviz® (ranibizumab biosimilar)

September 9, 2021

Samsung Bioepis announced results from a post-hoc and subgroup analysis of a Ph III clinical study of Byooviz® (ranibizumab biosimilar). Samsung Bioepis reported that the data supports biosimilarity between Byooviz® and reference ranibizumab.

CA | EU | US | Bio-Thera Solutions and Sandoz enter into agreement for bevacizumab biosimilar

September 8, 2021

Bio-Thera Solutions announced that it has entered into a commercialisation and license agreement with Sandoz to commercialise BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Sandoz will commercialise the product in the US, Europe, Canada and other international markets in exchange for an upfront payment, potential milestone payments and royalties on product sales.

EU | EMA approves Byooviz® (biosimilar ranibizumab)

September 8, 2021

The EMA approved Samsung Bioepis and Biogen’s Byooviz® (biosimilar ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular oedema, proliferative diabetic retinopathy, macular edema and choroidal neovascularisation.

Adaptimmune Therapeutics and Genentech enter into strategic collaboration

September 7, 2021

Adaptimmune Therapeutics announced it has entered into a strategic collaboration and license agreement with Genentech to develop and commercialise allogeneic cell therapies for multiple oncology indications.

Fresenius Kabi releases new data on MSB11456 (proposed biosimilar tocilizumab)

September 7, 2021

Fresenius Kabi announced that its biosimilar tocilizumab candidate MSB11456 successfully met its primary and secondary endpoints in Ph I trials of both subcutaneous and intravenous formulations.

AU | Australia’s TGA approves Gilead Sciences’ Trodelvy® (sacitizumab)

September 6, 2021

Australia’s TGA approved Gilead Sciences’ Trodelvy® (sacitizumab) for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer.

AU | Australia’s TGA approves Mylan/Alphapharm’s Abevmy® (biosimilar bevacizumab)

September 6, 2021

Australia’s TGA approved Mylan/Alphapharm’s Abevmy® (biosimilar bevacizumab) for the treatment of colorectal cancer, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube, peritoneal cancer and cervical cancer.

IN | Hetero receives emergency use approval in India for tocilizumab

September 6, 2021

Hetero announced that it has received emergency use approval from India’s DCGI to market its biosimilar tocilizumab for the treatment of COVID-19.

Dr Reddy’s sells E7777 (an engineered IL-2-diptheria toxin fusion protein) rights to Citius Pharmaceuticals

September 4, 2021

Dr Reddy’s announced that it has sold all of its rights to E7777 (an engineered IL-2-diptheria toxin fusion protein) to Citius Pharmaceuticals. Under the agreement, Dr Reddy’s will receive $40 million upfront, and milestone payments of up to $40 million (related to the cutaneous T-cell lymphoma indication) and $70 million (additional indication approvals).

CN | China’s NMPA approves JW Therapeutics’ Relma-cel (relmacabtagene autoleucel)

September 3, 2021

China’s NMPA approved JW Therapeutics’ Relma-cel (relmacabtagene autoleucel) for the treatment of large B-cell lymphoma.

UK | The UK’s NICE recommends Novartis’ Cosentyx® (secukinumab)

September 3, 2021

The UK’s NICE recommended Novartis’ Cosentyx® (secukinumab) as a treatment for plaque psoriasis in children aged 6-17 years.

US | Amgen and Hospira ready to settle Neupogen® (filgrastim) dispute

September 2, 2021

Amgen and Hospira appear ready to settle the ongoing dispute relating to Neupogen® (filgrastim). The matter was due to go to a jury trial on 20 September 2021.

EU | The UK’s NICE recommends UCB Pharma’s Bimzelx® (bimekizumab)

September 1, 2021

The UK’s NICE recommended UCB Pharma’s Bimzelx® (bimekizumab) as a treatment for plaque psoriasis in adults.

AU | AU’s TGA approves Celgene’s Reblozyl® (luspatercept)

August 30, 2021

Australia’s TGA approved Celgene’s Reblozyl® (luspatercept) for the treatment of transfusion-dependent anaemia.

IN | India’s DCGI approves Enzene’s biosimilar denosumab

August 27, 2021

India’s DCGI granted marketing authorisation for Enzene Bioscience’s biosimilar denosumab.

US | Bio-Thera and Hikma sign commercialisation agreement for ustekinumab biosimilar

August 27, 2021

Bio-Thera Solutions and Hikma Pharmaceuticals announced that they have signed an exclusive commercialisation and license agreement for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Hikma will gain exclusive commercialisation rights in the US with a first-right-to-negotiate to add Europe (excluding CIS countries) to the agreement.

US | Two former JHL Biotech executives plead guilty to conspiracy to steal trade secrets and commit wire fraud exceeding $101 million

August 26, 2021

Two former executives of JHL Biotech plead guilty to conspiracy to steal trade secrets and commit wire fraud exceeding $101 million in the US District Court for the Northern District of California. The written plea agreements disclosed that the executives used confidential, proprietary and trade secret information from Genentech to accelerate the timeline and reduce the costs of JHL Biotech’s development and production of Genentech biosimilars.

US | US District Court refuses to dismiss AbbVie’s Humira® infringement suit

August 26, 2021

The US District Court for the Northern District of Illinois refused to dismiss AbbVie’s Humira® (adalimumab) infringement suit against Alvotech hf. The court found that AbbVie is not required to sue the US based subsidiary listed on the aBLA form, but could sue Icelandic company Alvotech hf.

NZ | NZ’s Pharmac considering changes to adalimumab funding arrangements

August 26, 2021

NZ’s Pharmac announced that it is considering awarding Principal Supply to Amgevita® (biosimilar adalimumab). Pharmac is seeking feedback on the proposed changes to the funding arrangements.

US | US Federal Court reverses CAR-T infringement decision

August 26, 2021

The US Federal Circuit reversed an infringement judgement against Kite Pharma (part of Gilead Pharma) of a patent relating to CAR-T therapies on the basis of lack of written description.  The Sloan Kettering Institute for Cancer Research owned patent at issue was licenced exclusively to Juno Therapeutics (now part of BMS).  Kite Pharma’s CAR-T therapy is Yescarta® (axicabtagene ciloleucel), which competes with Juno’s Breyanzo® (lisocabtagene maraleucel).

Cipla and Kemwell announce new biosimilars joint venture

August 25, 2021

Cipla and Kemwell Biopharma announced that they have executed a joint venture agreement to develop, manufacture and commercialise biosimilars, with an aim to enter the respiratory biosimilars space.

EU | EU approves UCB’s Bimzelx® (bimekizumab)

August 24, 2021

UCB announced that it has gained EU marketing approval for Bimzelx® (bimekizumab), an IL-17A and IL-17F inhibitor indicated for the treatment of adults with moderate to severe plaque psoriasis.

UK | UK’s MHRA grants conditional marketing authorisation for Regeneron’s COVID-19 antibody cocktail

August 20, 2021

The UK’s MHRA granted conditional marketing authorisation for REGEN-COV®/Ronapreve® (casirivimab and imdevimab antibody cocktail) to prevent and treat acute COVID-19 infection.

AU | AU’s TGA approves Skyrizi® (risankizumab) in 150mg/mL formulation

August 19, 2021

Australia’s TGA granted approval for AbbVie’s Skyrizi® (risankizumab) in a higher, 150mg/mL  concentration formulation. Skyrizi® is indicated for plaque psoriasis in adults.

CN | China’s NMPA approves expanded label for Cosentyx® (secukinumab)

August 17, 2021

Novartis announced that China’s NMPA has expanded its approval of Cosentyx® (secukinumab) to include the treatment of plaque psoriasis in paediatric patients.

Novartis announces results of Ph III trials of Beovu® (brolucizumab) versus aflibercept

August 17, 2021

Novartis announced the results of its Ph III trials of Beovu® (brolucizumab) versus aflibercept in patients with diabetic macular edema, reporting that Beovu® demonstrated superiority versus aflibercept in key endpoints.

US | FDA announces 2022 Biosimilar User Fee Act rates

August 17, 2021

The FDA announced the Biosimilar User Fee Act rates for the 2022 fiscal year. The new rates will apply from 01 October 2021.

AU | Roche notifies AU’s TGA of tocilizumab shortages

August 13, 2021

Roche notified Australia’s TGA of shortages of multiple presentations of Actemra® (tocilizumab). Tocilizumab has been used off-label for COVID-19, driving global demand. The TGA made a number of recommendations for patients currently treated with Actemra®, including switching to alternative biological disease modifying drugs.

Progenity released its Q2 2021 financial results

August 12, 2021

Progenity released its Q2 2021 financial results. Progenity disclosed that it has recently produced a GMP drug substance batch for its adalimumab oral biotherapeutics delivery system (PGN-0B1).

BR | Brazil’s ANVISA grants emergency use authorisation for regdanvimab

August 12, 2021

Brazil’s ANVISA granted emergency use authorisation (EUA) for Celltrion’s COVID‑19 treatment regdanvimab. 

JP | Celltrion’s Herzuma® captures 51% of Japanese market

August 11, 2021

Celltrion announced that Herzuma® (biosimilar trastuzumab) gained 51% of the market share in Japan in June.

IN | Enzene Biosciences gains Indian approval of its romiplostim biosimmilar

August 10, 2021

Enzene Biosciences announced that India’s DCGI has approved its biosimilar romiplostim for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults.

New study reports on the safety and efficacy of BI695501 (biosimilar adalimumab)

August 10, 2021

A new study published in the The Lancet reported that the safety and efficacy of Boehringer Ingelheim’s BI695501 (adalimumab biosimilar) in patients with Crohn’s disease is similar to reference adalimumab.

Viatris releases Q2 2021 financial results

August 9, 2021

Viatris released its Q2 2021 financial results, reporting 8% growth in operational change for net sales of biosimilars and complex generics.

Opthea commences recruitment for Ph III trials of OPT-302

August 9, 2021

Opthea commenced recruitment for its Ph III trials of OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in the treatment of wet (neovascular) age-related macular degeneration.

US | Formycon and Bioeq submit BLA for proposed ranibizumab biosimilar

August 5, 2021

Formycon and Bioeq announced that the BLA for FYB201 (proposed ranibizumab biosimilar) has been submitted to the FDA.

Coherus Biosciences releases its Q2 2021 financial results

August 5, 2021

Coherus Biosciences released its Q2 2021 financial results. Coherus announced that its partner, Junshi Biosciences plans to submit the BLA for toripalimab for a number of indications later this quarter. Coherus also disclosed that it anticipates a mid-2022 target action date for its BLA for biosimilar ranibizumab, and confirmed it plans to launch its biosimilar adalimumab on or after 1 July 2023.

New study reports on ABP980 and pertuzumab administered as an admixture

August 5, 2021

A new study reported that the safety profiles and pharmacokinetic parameters of Amgen’s ABP980 (biosimilar trastuzumab) and pertuzumab administered as an admixture in a single infusion bag is consistent with what is known for reference trastuzumab and pertuzumab.

Outlook Therapeutics reports positive data from Ph III trials of bevacizumab biosimilar

August 3, 2021

Outlook Therapeutics reported positive efficacy and safety data from Ph III trials of ONS-5010 (proposed bevacizumab biosimilar) for the treatment of neovascular age-related macular degeneration.

Amgen released its Q2 2021 financial results

August 3, 2021

Amgen released its Q2 2021 financial results, reporting double digit volume growth for Prolia® (denosumab), Repatha® (evolocumab), Mvasi® (biosimilar bevacizumab) and Kanjinti® (biosimilar trastuzumab).

BR | Celltrion wins tender to supply Brazilian market with trastuzumab and rituximab

August 3, 2021

Celltrion announced it has won a tender to supply the Brazilian market with Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab).

AbbVie releases Q2 2021 financial results

July 30, 2021

AbbVie released its Q2 2021 financial results, reporting US Humira® (adalimumab) net revenues increased 7.1%, but decreased internationally 12.6% on an operational basis. AbbVie attributed this decrease to biosimilar competition.

American Academy of Ophthalmology pushed back against pressure to use bevacizumab biosimilars off-label

July 29, 2021

The American Academy of Ophthalmology pushed back against insurance company pressure to use new bevacizumab biosimilars off-label in eye treatment as alternatives to Avastin® (bevacizumab) in the absence of supporting studies.

New study indicates pembrolizumab in combination with cetuximab shows promise as treatment for head and neck squamous cell carcinoma

July 29, 2021

A new study published in Lancet Oncology reported that pembrolizumab in combination with cetuximab shows promise as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.

US | FDA approves first interchangeable biosimilar insulin product

July 29, 2021

The FDA announced it has approved the first interchangeable biosimilar insulin product. Semglee® (biosimilar insulin glargine) has been approved as an interchangeable biosimilar to Lantus® and is indicated for adults and paediatric patients with Type 1 diabetes and in adults with Type 2 diabetes.

Prestige BioPharma trastuzumab biosimilar demonstrates equivalent pharmacokinetic and safety profile to reference trastuzumab

July 28, 2021

Prestige BioPharma announced that HD201 (proposed trastuzumab biosimilar) demonstrated an equivalent pharmacokinetic and safety profile to reference trastuzumab in a bridging study completed last year.

Abenza and BioXpress form new biosimilar partnership

July 27, 2021

Abenza and BioXpress Therapeutics announced they have formed a new partnership to support biosimilar development and manufacturing.

US | Pfizer and J&J settle Inflectra® antitrust suit

July 23, 2021

Pfizer and Johnson & Johnson (J&J) settled the antitrust litigation relating to Pfizer’s Inflectra® (infliximab biosimilar). Pfizer had alleged that J&J’s payer contracts restricted the use of Inflectra® by denying reimbursement unless Remicade was first proven ineffective for patients, causing a reluctance among pharmacies to stock Inflectra®. Details of the settlement have not been published.

New study confirms safety and efficacy of Celltrion’s adalimumab biosimilar

July 22, 2021

A new study published in Rheumatology reported that the safety and efficacy of Celltrion’s CT-P17 (biosimilar adalimumab) were comparable after one year of treatment, including for patients who switched from reference adalimumab after 24 weeks.

Intas Pharma and Meiji and Dong-A St sign commercialisation agreement for ustekinumab biosimilar

July 22, 2021

Intas Pharma announced it has signed a commercialisation agreement with Meiji and Dong-A St for DMB-3115 (proposed ustekinumab biosimilar). Under the agreement, Intas will receive exclusive licensing rights to DMB-3115 worldwide excluding Japan, Korea and certain countries in Asia.

Inhalon Biopharma and Celltrion to partner on inhaled form of regdanvimab for treatment of COVID-19

July 22, 2021

Inhalon Biopharma announced it will partner with Celltrion to develop IN-006, an inhaled form of regdanvimab for the treatment of COVID-19. It is hoped that the product will be able to reach the virus in the airways and allow patients to self-administer treatment at home. Last week we reported that regdanvimab demonstrated strong neutralising activity against the Delta variant of COVID-19 in pre-clinical studies.

CN | NMPA grants marketing approval for Mabpharm’s infliximab ‘biobetter’

July 20, 2021

Sorrento announced that China’s NMPA has granted marketing approval for Mabpharm’s infliximab ‘biobetter’. Sorrento holds exclusive commercial rights to the product outside of China and disclosed that it plans to file a BLA in the EU and US in 2021.

Samsung Bioepis commences Ph III ustekinumab trials

July 19, 2021

Samsung Bioepis announced that it has commenced Ph III trials of SB17 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

Shanghai Henlius Biotech doses first patient in Ph I bevacizumab trials

July 19, 2021

Shanghai Henlius Biotech announced that the first patient has been dosed in its Ph I clinical trial of HLX04-O (proposed bevacizumab biosimilar) in the treatment of wet age-related macular degeneration.

Celltrion announces regdanvimab demonstrates strong neutralising activity against COVID-19 delta variant

July 16, 2021

Celltrion announced pre-clinical in vivo studies of CT-P59 (regdanvimab) demonstrated strong neutralising activity against the Delta variant of COVID-19. Celltrion reported a 100% survival rate after a clinically relevant dose compared to 0% for the placebo group, with significant protection against body weight loss after viral challenge. A therapeutic dosage of CT-P59 also significantly reduced the viral load and inflammation in the lungs compared to non-treated controls.

Bio-Thera Solutions doses first patient in ustekinumab trials

July 15, 2021

Bio-Thera Solutions announced that the first patient has been dosed in its Ph III trials of BAT206 (proposed ustekinumab biosimilar).

UK | UK’s NICE recommends biologics for treatment of moderate RA

July 14, 2021

The UK’s NICE finalised its guidance on the treatment of moderate rheumatoid arthritis, recommending the use of adalimumab, etanercept, infliximab and abatacept for patients with moderate rheumatoid arthritis which is inadequately controlled on conventional therapies.

US | Amgen warned by FDA over Neulasta® claims

July 14, 2021

The FDA notified Amgen of its concerns relating to potential false or misleading promotional communications about Neulasta® (pegfilgrastim). The FDA alleged that promotional materials released by Amgen made false or misleading claims and representations about the benefit of Neulasta® when administered through the Onpro injection compared to a prefilled syringe. Amgen must provide a written response within 15 working days from the date of receipt of the letter.

Boditech Med receives export approval for AFIAS Adalimumab diagnostic kit

July 12, 2021

Boditech Med announced it has obtained export approval for AFIAS Adalimumab, a diagnostic kit which measures adalimumab levels in blood. The test is able to return a result within 10 minutes using whole blood on-site.

US | US President Biden signs executive order supporting generic and biosimilar drugs

July 9, 2021

US President Biden signed an executive order aimed at promoting competition in the US economy. The order directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, and encourages the FTC to ban ‘pay for delay’ agreements.

AU | AU’s PBAC recommends listing Mvasi, Keytruda and Stelara

July 6, 2021

Australia’s PBAC recommended the listing of Amgen’s Mvasi® (biosimilar bevacizumab). The PBAC also recommended listing Keytruda® (pembrolizumab) for the first line treatment of unresectable or metastatic mismatch repair deficient colorectal cancer and recommended listing Stelara® (ustekinumab) for the treatment of paediatric patients with severe chronic plaque psoriasis.

US | FDA grants fast track designation to Opthea’s OPT-302

July 6, 2021

Opthea announced the FDA has granted fast track designation for OPT-302 (VEGF-C/-D ‘trap’ inhibitor). OPT-302 (a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3)) is intended to treat neovascular (wet) age-related macular degeneration in combination with anti-VEGF-A therapy.

IN | India’s CDSCO grants marketing authorisation for Lupin’s ranibizumab biosim

July 6, 2021

India’s Central Drugs Standard Control Organisation granted marketing authorisation for Lupin’s ranibizumab biosimilar.

CA | Quebec releases details of its biosimilars switching program

July 6, 2021

The Government of Quebec released the details of its biosimilars switching program. Under the new program, patients will continue to be reimbursed for biologics for ongoing treatment until 13 April 2022. After this date, patients will only be reimbursed for biologics for which there is no covered biosimilar version, the request is for a pregnant woman or child, or there is a case of a therapeutic failure.

US | FDA approves expanded label for Keytruda® (pembrolizumab)

July 6, 2021

Merck announced that the FDA has approved an expanded label for Keytruda® (pembrolizumab). Keytruda® is now also approved for the treatment of patients with recurrent of metastatic or locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

Alvotech does first patient in AVT04 (proposed ustekinumab) trials

July 6, 2021

Alvotech announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study for AVT04 (proposed ustekinumab biosimilar). The trial is being conducted in Central and Eastern Europe and approximately 530 patients are expected to be enrolled in the study.

Chong Kun Dang and Menagen sign agreement for Nesbell® (biosimilar darbepoetin alfa)

July 5, 2021

Chong Kun Dang announced it has signed a commercialisation agreement with Menagen for Nesbell® (biosimilar darbepoetin alfa). Under the agreement, Chong Kun Dang will receive a down payment and milestone payments in exchange for exclusive commercialisation rights in Oman, Saudi Arabia, UAE, Kuwait Qatar and Bahrain.

Gan & Lee Pharmaceuticals announce positive Ph I results for insulin analog biosimilars

July 2, 2021

Gan & Lee Pharmaceuticals announced positive Ph I results for its three proposed insulin analog biosimilars (insulin aspart, insulin lispro and insulin glargine). Gan & Lee announced that all three Ph I studies met their primary PK and primary PD analyses.

STADA and XBrane provide update on Xlucane™ (proposed ranibizumab biosimilar)

June 29, 2021

STADA and XBrane BioPharma announced that Xlucane™ (proposed ranibizumab biosimilar) met its primary endpoint in a pivotal comparability trial. STADA disclosed that it plans to submit the MAA and BLA for Xlucane™ to the EMA and FDA respectively in the second half of 2021.

New data on Luye Pharmaceuticals’ proposed bevacizumab biosimilar published

June 29, 2021

A new study published in Cancer Communications concluded that Luye Pharmaceuticals’ LY01008 (proposed bevacizumab biosimilar) demonstrated similarity to reference Avastin® in terms of efficacy and safety in patients with advanced or recurrent non-squamous non-small cell lung cancer

EU | Bioeq submits MAA for proposed ranibizumab biosimilar

June 29, 2021

Bioeq announced that it has submitted the MAA for FYB201 (proposed ranibizumab biosimilar) to the EMA. Under the agreement announced on 28 June 2021, FYB201 will be marketed in the EU by Teva.

Teva and Bioeq enter biosimilar ranibizumab agreement

June 28, 2021

Teva and Bioeq announced they have entered into a strategic partnership for the exclusive commercialisation of Bioeq’s FYB201 (proposed ranibizumab biosimilar). Under the agreement, Bioeq will be responsible for the development, registration and supply of the product, while Teva will gain commercialisation rights in Europe, Canada, Israel and New Zealand.

CN | NMPA approves sNDA for Tyvyt® (sintilimab) in combination with Byvasda® (biosimilar bevacizumab)

June 27, 2021

Innovent Biologics announced China’s National Medical Products Administration has approved its supplemental New Drug Application for Tyvyt® (sintilimab) in combination with Byvasda® (biosimilar bevacizumab) as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma.

EU | CHMP recommends Bimzelx® (bimekizumab)

June 25, 2021

UCB announced that the CHMP has recommended BIMZELX® (bimekizumab) for the treatment of plaque psoriasis.

EU | CHMP recommends Byooviz™ (proposed ranibizumab biosimilar)

June 25, 2021

Samsung Bioepis and Biogen announced that the CHMP has recommended BYOOVIZ™/SB11 (proposed ranibizumab biosimilar) for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization.

EU | CHMP recommends Minjuvi® and Abecma®

June 24, 2021

The CHMP recommended granting conditional marketing authorisation for Minjuvi® (tafasitamab) for the treatment of relapsed or refractory diffuse large B-cell lymphoma, and Abecma® (idecabtagene vicleucel) for the treatment of relapsed and refractory multiple myeloma.

EU | CHMP recommends expanding Opdivo® and Rinvoq® indications

June 24, 2021

The Committee for Medicinal Products for Human Use (CHMP) recommended expanding the indications for Opdivo® (nivolumab) and Rinvoq® (upadacitinib). If approved, Opdivo® will also be indicated for oesophageal or oesophageal junction cancer. If approved, Rinvoq® will also be indicated for atopic dermatitis.

US | Cigna announces payment for biosimilar switch

June 24, 2021

Health insurance provider Cigna announced it will offer a one-time US$500 payment to patients who switch to a biosimilar or another preferred medication. This payment will be provided in a debit card and can be spent on health care services and products.

Innovent announces results of Ph III trials of sintilimab

June 23, 2021

Innovent Biologics announced its Ph III trials of sintilimab in combination with chemotherapy met the overall survival primary endpoint.

US | FDA accepts BLA for Genentech’s ranibizumab Port Delivery System

June 23, 2021

Genentech announced that the FDA has accepted the BLA for its Port Delivery System (PDS) with ranibizumab under Priority Review. Genentech is seeking approval for its PDS for the treatment of wet, or neovascular, age-related macular degeneration (AMD).

Nichi-Iko and Laboratorio Elea Phoenix announce deal for biosimilar infliximab

June 17, 2021

Nichi-Iko announced it has entered a licence and supply agreement with Laboratorio Elea Phoenix for a biosimilar infliximab product. Under the agreement Nichi-Iko will supply the product to Elea for the Argentine market.

US | FDA accepts BLA for Amneal’s proposed bevacizumab biosimilar

June 17, 2021

Amneal announced the FDA has accepted the BLA for Alymsys™ (proposed bevacizumab biosimilar). Alymsys™ was developed in collaboration with mAbxience.

Alvotech reaches primary completion date in AmAb switching study

June 15, 2021

Alvotech announced it has reached the primary completion date in its switching study for AVT02 (proposed adalimumab biosimilar). Alvotech hopes to list AVT02 as an interchangeable adalimumab biosimilar in the US, which would allow for pharmacy substitution.

Celltrion presents data for Truxima® in patients with DLBCL

June 12, 2021

Celltrion presented data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress. Celltrion reported that the response rates, survival rates and overall safety profile of Truxima® appeared consistent with those reported for the reference product.

AU | CH | EU | UK | Theramex enters agreement with Enzene Biosciences for biosimilar denosumab

June 10, 2021

Theramex UK announced it has entered into an agreement with Enzene Biosciences for the commercialisation of a biosimilar denosumab. Under the agreement, Enzene will supply Theramex with the product for commercialisation in Europe, the UK, Switzerland and Australia.

UK | UK’s NICE recommends biologics for moderate RA

June 10, 2021

The UK’s NICE published final draft guidance recommending adalimumab, etanercept and infliximab for the treatment of moderate rheumatoid arthritis on the NHS. Previously, biologics had been recommended only for severe rheumatoid arthritis.

US | Magellan Rx Management announces biosimilar program saved US$40 million

June 9, 2021

Magellan Rx Management announced that its oncology biosimilar medical benefit drug management solution has saved customers over US$40 million, with greater savings expected as the market shift to biosimilars accelerates.

Bio-Thera commences Ph I trials of BAT2506 (proposed golimumab biosimilar)

June 8, 2021

Bio-Thera announced it has initiated Ph III trials of BAT2506 (golimumab biosimilar).

Merck releases new data on Keytruda® (pembrolizumab) in combination with Lenvima® (levatinib)

June 7, 2021

Merck released new data on Keytruda® (pembrolizumab) in combination with Lenvima® (levatinib) versus sunitinib in patients with advanced renal cancer. Merck said that the results reinforced the combination of pembrolizumab and levatinib as a potential new treatment option for renal cancer.

CA | Celltrion launches Remsima SC® (biosimilar infliximab) in Canada

June 7, 2021

Celltrion launched Remsima SC® (subcutaneous infliximab biosimilar) in Canada.  Remsima SC® is indicated for the treatment of rheumatoid arthritis.

EU | Celltrion to launch Yuflyma® (biosimilar adalimumab) in the EU in June

May 31, 2021

The Korea Herald has reported that Celltrion will launch Yuflyma® in the EU in June.  Citing ‘industry sources’ and a Celltrion official, the article discloses that Celltrion will initially launch Yuflyma® in six EU countries including Spain, before launching in an additional 7 EU countries in Q3 2021, and 3 more in Q4 2021.

UK | UK recommends Tremfya® (guselkumab) for the treatment of plaque psoriasis and psoriatic arthritis

May 28, 2021

The UK’s NICE recommended Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis and psoriatic arthritis.

Sun Pharma to develop biosimilars

May 28, 2021

Sun Pharma announced in its Q1 2021 earnings call that it will develop biosimilar products which have ‘significant future expiry dates’, aiming to be among the first approvals of ‘third wave’ biosimilar products.

AbbVie to present new data on its immunology products

May 25, 2021

AbbVie announced it will present new data from a number of studies on its immunology products including Rinvoq® (upadacitinib), Skyrizi® (risankizumab) and Humira® (adalimumab) at the EULAR 2021 Virtual Congress of Rheumatology.

BioFactura initiates Ph I trials of ustekinumab biosimilar

May 25, 2021

BioFactura announced the initiation of Ph I trials of BFI-751 (proposed ustekinumab biosimilar). The trial is being conducted across three sites in Australia and New Zealand.

 

IN | Zydus Cadila launches trastuzumab emtansine in India

May 24, 2021

Zydus Cadila announced it has launched Ujvira (trastuzumab emtansine) in India. Ujvira is an antibody drug conjugate biosimilar and is available in 100mg and 160mg vials at a considerable discount to the reference product.

Meiji Seika Pharma releases results of Ph I trials of ustekinumab biosimilar

May 20, 2021

Meiji Seika Pharma announced its Ph I trials of DMB-3115 (proposed ustekinumab) biosimilar demonstrated the bioequivalence of its product to the reference product.

US | US House of Reps Oversight Committee publishes scathing report on Humira®

May 20, 2021

The US House of Representatives Committee on Oversight and Reform published a Drug Pricing Investigation Staff Report which was scathing regarding AbbVie’s conduct regarding the sale of its blockbuster drugs Humira® (adalimumab) and Imbruvica® (ibrutinib) in pursuing ‘a variety of tactics to increase drug sales while raising prices for Americans, including exploiting the patent system to extend its market monopoly, abusing orphan drug protections to further block competition, and engaging in anti-competitive pricing practices.’. 

US | Sandoz appeal to US Supreme Court dismissed

May 18, 2021

The US Supreme Court declined to hear Novartis’ appeals against a lower court decision which upheld two Amgen patents relating to Enbrel® (etanercept).  Keren Haruvi, President of Sandoz US and Head of North America estimates that a biosimilar etanercept in the US could have saved payees USD$1 billion annually.

Prestige BioPharma announces new deal with Busan City Government

May 18, 2021

Prestige BioPharma announced it has entered into a memorandum of understanding with the Busan City Government for the establishment of a R&D centre in Busan, South Korea.  Prestige announced that the 45,000 m2 centre will house 209 new R&D personnel for the next five years.  Prestige also announced that it has completed Ph III trials of its proposed trastuzumab biosimilar, and an application is currently under EMA review.

CA | Quebec introduces biosimilar switching program

May 18, 2021

The Government of Quebec announced it would introduce a biosimilar switching program which is expected to generate annual savings of more than CAD$100 million.  All patients in Quebec currently on biologics must switch to a biosimilar by April 12, 2022.  This follows similar moves from Alberta, New Brunswick and British Columbia.

 

CA | Sandoz launches biosimilar enoxaparin sodium in Canada

May 17, 2021

Sandoz Canada launched Inclunox® (biosimilar enoxaparin sodium) in Canada.

New study indicates patients with sarcoidosis can safely switch to infliximab biosimilars

May 14, 2021

Sarcoidosis News reported a new study demonstrates that patients with sarcoidosis can safely switch from Remicade® (infliximab) or Inflectra® (biosimilar infliximab) to Flixabi® (biosimilar infliximab) and maintain similar clinical benefits.  Infliximab is not indicated for sarcoidosis, but is commonly used off-label and has been shown to improve lung function in refractory patients.

AU | Alphapharm receives AU approval for adalimumab biosimilar

May 14, 2021

Alphapharm received approval for Hulio® (biosimilar adalimumab) in Australia.  Hulio® was approved in a 20mg/0.4mL solution for pre-filled syringe, 40mg/0.8mL solution for pre-filled syringe, and 40mg/0.8mL solution for pre-filled pen.  Viatris launched Hulio® in Canada and Japan in February this year.

Celltrion reports Q1 2021 financial results

May 12, 2021

Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%.  Celltrion announced that it is planning to complete Ph III trials of biosimilar bevacizumab in the first half of 2021, and that ustekinumab, aflibercept, omalizumab and denosumab candidates remain in Ph III trials.

UK | UK’s MHRA finalises biosimilar guidance

May 12, 2021

The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) finalised its ‘Guidance on the licensing of biosimilar products‘, outlining the licensing requirements for biosimilars in the post-Brexit UK.  The MHRA had previously foreshadowed in its draft guidance that comparative efficacy/safety trials would not be necessary for most biosimilars.  The MHRA has maintained its position in this finalised guidance, stating that ‘Although each biosimilar development needs to be evaluated on a case by case basis, it is considered that, in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach.‘.

Alvotech takes front foot approach and commences suit against AbbVie

May 11, 2021

Alvotech filed a federal lawsuit against AbbVie in the US District Court of the Eastern District of Virginia, seeking to clear patent barriers relating to biosimilar adalimumab, AVT02.  Alvotech alleges that AbbVie has sought to protect its product monopoly by ‘overwhelming’ Alvotech with 60+ patent claims with questionable validity.  Specifically, Alvotech alleges that AbbVie has acted improperly by:

  • patenting purported inventions that it does not use in the production of Humira®
  • seeking multiple patents on the same invention but as part of different patent families in a manner designed to cause confusion;
  • obtaining patents through inequitable conduct;
  • by seeking patents that cover Humira® already in the prior art; and
  • obtaining patents on purported inventions that AbbVie did not invent.

AbbVie’s Humira® still holds a monopoly in the US, despite biosimilars being available in the EU, Japan, Canada and Australia.

Coherus reports Q1 2021 financial results

May 6, 2021

Coherus BioSciences reported its Q1 2021 financial results.  Coherus disclosed that it has commenced the rolling submission of the BLA for toripalimab and that it expects to file the BLA for CHS-201 (proposed ranibizumab biosimilar) mid-2021.

CA | Alberta expands biosimilar switching program

May 6, 2021

The Government of Alberta announced it has expanded its biosimilars switching program to include adalimumab for all originator indications except pediatric juvenial idiopathic arthritis. All adult patients on Humira® will be switched to Amgevita®, Hadlima®, Hulio®, Hyrimoz® or Idacio® by 01 May 2022.  This follows extensions made to biosimilar switching programs by British Columbia and New Brunswick last month.

IN | Hetero submits application for biosimilar tocilizumab

May 5, 2021

ThePrint reported that Hetero Labs has submitted an application to start clinical trials and manufacture of biosimilar tocilizumab in India. Tocilizumab has been recommended for off-label use in the treatment of COVID-19 by the Indian Government, but has been subject to extreme shortages.  The product is manufactured by Roche and distributed in India by Cipla pharmaceuticals. It is not known whether Hetero has reached a licensing agreement with Roche.

CA | Amgen launches Amgevita® (biosimilar adalimumab) in Canada

May 4, 2021

Amgen launched Amgevita® (biosimilar adalimumab) in Canada. Amgevita® is available in 50mg/mL PFS and pen presentations and is citrate-free. Amgevita® will be reimbursed on the public drug plans in BC, Alberta, Ontario, Quebec, New Brunswick and Newfoundland.

Merck reports its vision for Organon

May 3, 2021

Merck reported the vision, focus and business model for its new standalone company, Organon.  Merck disclosed that Organon with have a direct sales presence in 58 markets, with key growth drivers in Organon’s biosimilars portfolio expected to be Renflexis® (biosimilar infliximab), Aybintio® (biosimilar bevacizumab) and Hadlima® (biosimilar adalimumab).

Sandoz to commence Ph III trials of aflibercept biosimilar

May 3, 2021

Sandoz announced it will commence enrolling patients in MYLIGHT, its Ph III efficacy and safety study of its proposed aflibercept biosimilar.  MYLIGHT will assess the efficacy and safety of the biosimilar candidate in comparison to Eylea® in patients with neovascular age-related macular degeneration.

EU | US | Samsung Bioepis presents similar data for proposed ranibizumab biosimilar

May 1, 2021

Samsung Bioepis announced a new study demonstrating the structural, physicochemical and biological similarity between its SB11 (proposed ranibizumab biosimilar) and Lucentis®.  The BLA and MA for SB11 are currently before the FDA and EMA respectively.

Biocon reports its Q1 2021 financial results

April 29, 2021

Biocon reported its Q1 2021 financial results.  Biocon reported its biosimilars revenues increased 53% year-on-year.  Biocon identified its pegfilgrastim and trastuzumab biosimilars as key growth drivers.

Biocon receives ISPE award for mAb manufacturing facility

April 28, 2021

Biocon announced it has received the 2021 Facility of the Year Award from the International Society for Pharmaceutical Engineering for its new monoclonal antibody manufacturing facility at Biocon Park, Bengaluru.

Teva reports its Q1 2021 financial results

April 28, 2021

Teva reported its Q1 2021 financial results.  Teva’s overall year-on-year revenues decreased 10% in local currency terms, but its generic and biosimilar revenues increased 11% year-on-year.  In particular, Truxima® (biosimilar rituximab) was recognised as a key growth driver.

EU | Biocon receives EC authorisation for Abevmy® (biosimilar bevacizumab)

April 27, 2021

Biocon announced it has received EC marketing authorisation for Abevmy® (biosimilar bevacizumab).  This follows the positive recommendation made by the CHMP for Abevmy® on 01 March 2021.

US | President Biden signs new biosimilar legislation into law

April 26, 2021

President Biden signed into law the Advancing Education on Biosimilars Act of 2021. As we previously reported, this bill was introduced to the Senate in March 2021, and was passed by the House of Representatives on 14 April.  The Advancing Education on Biosimilars Act aims to improve confidence in the safety and effectiveness of biosimilars by providing patients and providers with educational materials.

AU | PBAC publishes March outcomes

April 26, 2021

Australia’s PBAC published the outcomes of its March 2021 meeting. The recommendations include:

  • Mvasi® (Amgen’s biosimilar bevacizumab): the PBS listing has been changed to an unrestricted benefit to allow access to combination treatment with atezolizumab.
  • Beovu® (brolucizumab): Beovu® was recommended for subfoveal choroidal neovascularisation due to AMD.
  • Keytruda® (pembrolizumab): PBAC recommended Section 100 Authority Required listing for the treatment of metastatic colorectal cancer.

New study indicates bimekizumab is noninferior and superior to adalimumab

April 23, 2021

A new study sponsored by UCB Biopharma SPRL indicates that bimekizumab is noninferior and superior to adalimumab at 16 weeks in the treatment of plaque psoriasis.

Samsung Bioepis releases its Q1 2021 financial results

April 23, 2021

Samsung Bioepis released its Q1 2021 financial results.  Global sales for Benepali® (biosimilar etanercept), Flixabi® (biosimilar infliximab) and Imraldi® (biosimilar adalimumab) increased 3.9% quarter-on-quarter, with Benepali® accounting for the largest share of those sales.

Boehringer Ingelheim reports on Ph III adalimumab switching study

April 23, 2021

Boehringer Ingelheim announced results from a Ph III switching study of Cyltezo® (biosimilar adalimumab) with Humira® produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity and safety.

CA | New Brunswick introduces biosimilar switching program

April 21, 2021

New Brunswick announced it has introduced a biosimilar switching program, expected to save the province $10 million once fully implemented. New Brunswick reported that government spending on biologics accounted for 29.4% of drug costs but only represented 1.5% of the total number of prescriptions paid. British Columbia, which operates a similar program, recently expanded its switching program to include adalimumab and etanercept.

Roche published Q1 2021 earnings report

April 21, 2021

Roche published its Q1 2021 earnings report, noting significant impacts from biosimilars. In particular, Roche attributed a combined sales reduction of CHF 1.6 billion to the impact of rituximab, bevacizumab and trastuzumab biosimilars.

CN | NMPA accepts Luye Pharma’s bevacizumab application

April 20, 2021

Luye Pharma announced its marketing authorisation application for LY01008 (proposed bevacizumab biosimilar) has been accepted by China’s National Medical Products Administration.

Huons Lab and PanGen Biotech to develop biosimilar denosumab

April 20, 2021

Huons Lab announced it has reached an agreement with PanGen Biotech for the development of biosimilar denosumab. Under the agreement, Huons Lab will gain access to PanGen Biotech’s cell line manufacturing and purification technology.

RU | Prestige Biopharma and Pharmapark reach biosimilar bevacizumab deal

April 15, 2021

Prestige Biopharma and Pharmapark announced they have reached an agreement for the commercialisation of Prestige Biopharma’s proposed bevacizumab biosimilar in the Russian Federation.

CN | NMPA approves Henlius’ IND application for HLX26

April 15, 2021

Shanghai Henlius Biotech announced China’s NMPA has approved its investigational new drug (IND) application of its HLX26 (recombinant anti-LAG-3 human monoclonal antibody) for treatment of solid tumors and lymphomas. Currently, there are no LAG-3 targeted products on the market.

US | New York state benefits from biosimilar preference initiative

April 15, 2021

The Centre for Biosimilars reported a poster presented at AMCP 2021 shows a New York state Medicaid biosimilar preference initiative was successful in increasing biosimilar use in 2019. Biosimilar substitution is not permitted at the pharmacy level in New York, and provider prescriptions are required. The switching program was supported by months of biosimilar promotion and education among plan beneficiaries who were receiving originator biologics.

US | House of Representatives passes new biosimilar legislation

April 14, 2021

Two bills aimed at lowering the cost of prescriptions were passed by the House of Representatives. As we previously reported, the Advancing Education on Biosimilars Act and Ensuring Innovation Act were introduced to the Senate in March 2021.

NKMax and Merck KGaA expand clinical trial and supply agreement

April 13, 2021

NKMax and Merck KGaA announced an expansion of its clinical trial and supply agreement to include a Ph I/IIa trial of SNK01 in combination with Erbitux® (cetuximab) in patients with locally advanced or metastatic non-small cell lung cancer.

Purple Biotech presents further preclinical data for NT219

April 13, 2021

Purple Biotech announced it presented further preclinical data supporting the mechanism of action of NT219 at the American Association of Cancer Research 2021 Annual Meeting. NT219 is being developed as a treatment for recurrent and/or metastatic solid tumors and squamous cell carcinoma of the head and neck cancer.

Alteogen completes Ph I trials of proposed aflibercept biosimilar

April 8, 2021

Alteogen announced it has completed Ph I trials of its proposed aflibercept biosimilar ALT-L9. Alteogen reported that the trial confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea®.

Biogen reaches agreement with Bio-Thera for tocilizumab biosimilar

April 8, 2021

Biogen announced it has reached an agreement with Bio-Thera for the development, manufacture and commercialisation of BAT1806 (proposed tocilizumab biosimilar). Under the agreement, Biogen will gain exclusive rights to BAT1806 in all countries excluding China.

EU | EU grants marketing authorisation for Tysabri® SC (natalizumab)

April 7, 2021

Biogen announced the EC has granted marketing authorisation for Tysabri® (natalizumab) in a subcutaneous presentation. Tysabri® SC is approved for the treatment of relapsing-remitting multiple sclerosis.

CA | BC expands its biosimilars switching program

April 7, 2021

British Columbia expanded its biosimilars switching program to include adalimumab, and expanded coverage of etanercept. BC announced that almost 6,000 patients currently treated with Humira® will be switched to either Amgevita® (Amgen), Hadlima® (Merck/Samsung), Hulio® (Mylan), Hyrimoz® (Sandoz) or Idacio® (Fresenius Kabi) over a 6 month period. New and existing plaque psoriasis patients currently being treated by Enbrel® will also be transitioned to Brenzys® (Samsung Bioepis/Merck) or Erelzi® (Sandoz) over the same period.

US | FDA approves new dosage regimen for Erbitux® (cetuximab)

April 6, 2021

The FDA approved a new dosage regimen for Erbitux® (cetuximab) for patients with K-RAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. The new dosage regimen allows for fortnightly dosing.

BR | PlantForm announces deal with Bio-Manguinhos/Fiocruz

April 6, 2021

PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the Brazilian market.

New AbbVie study reports upadacitinib is superior to adalimumab

March 31, 2021

A new AbbVie study published in the NEJM reports a 30mg dose of upadacitinib is superior to adalimumab in DMARD-refractory psoriatic arthritis (PsA). The percentage of patients with PsA who achieved an ACR20 response at week 12 was 78.5% of patients treated with 30 mg upadacitinib, compared to 65% of patients treated with adalimumab.

EU | Celltrion received a positive CHMP opinion for Remsima® subcut (subcutaneous infliximab)

March 31, 2021

Celltrion received a positive CHMP opinion for Remsima® subcut (subcutaneous infliximab). Remsima® SC was recommended for the direct use without IV loading in patients with rheumatoid arthritis.

EU | STADA launches Oyavas® (biosimilar bevacizumab) in the Netherlands and Germany

March 30, 2021

STADA launched Oyavas® (biosimilar bevacizumab) in the Netherlands and Germany. Oyavas® is indicated for carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

AU | CA | Samsung Bioepis launches Hadlima® (biosimilar adalimumab) in Australia and Canada

March 29, 2021

Samsung Bioepis announced on 29 March 2021 that it has launched Hadlima®, its 50mg/mL biosimilar adalimumab in Australia and Canada. Australia’s PBAC previously confirmed that Hadlima® would be PBS listed from 01 April 2021.

Alvotech denies AbbVie’s claims of trade secret piracy

March 26, 2021

Alvotech has disputed AbbVie’s claim filed in the Northern District of Illinois last week relating to AbbVie’s allegations of wrongdoing in the development of Alvotech’s biosimilar adalimumab product.  Alvotech notes “AbbVie waited over three years from the purported date of the alleged wrongdoing to file its case, doing so after the ex-AbbVie employee had already left Alvotech and without naming the ex-AbbVie employee as a defendant”, suggesting that these latest accusations may be part of AbbVie’s broader strategy to delay biosimilar competition.

AU | AU’s PBAC makes changes to adalimumab listings

March 26, 2021

A number of changes have been made to the PBS listings of adalimumab. From 1 April:

  • The Amgen, Merck/Samsung, Sandoz and Fresenius 50mg/ml products will be PBS listed and A flagged against the 50mg/ml Humira formulations for all approved indications; and
  • Humira 100mg/ml 20mg and 40mg products will be listed and A flagged against the 50mg/ml Humira formulations, and the 50mg/ml Humira product will be phased out over 12 months but cannot be prescribed after 1 April (ie the pharmacies will honour scripts written prior to 1 April).
  • Humira 100mg/ml 80mg syringe and pen products will be PBS listed but will not be A flagged as they are not considered equivalent to the “original” Humira formulation/product.

JP | LG Chem receives approval for its biosimilar adalimumab in Japan

March 25, 2021

Korea Biomedical Review reported that LG Chem has received approval from Japan’s Health Ministry for its biosimilar adalimumab. The product will be commercialised by Mochida Pharmaceuticals.

mAbxience announces new 4,000L CSR bioreactor

March 25, 2021

mAbxience announced it will install an ABEC 4,000L CSR bioreactor at its site in Leon, Spain. The system is expected to be installed within months, and will boost mAbxience’s biosimilar and CDMO manufacturing capacity.

EirGenix announced positive Ph III results for trastuzumab biosimilar

March 24, 2021

EirGenix announced that its Ph III clinical trial of EG12014 (proposed trastuzumab biosimilar) has met its primary endpoint. EirGenix announced that EG12014 has shown equivalent efficacy to Herceptin®, and demonstrated a comparable safety profile.

JP | Herzuma® gains 44% market share in Japan

March 17, 2021

The Korea Herald reported that Celltrion’s Herzuma® (biosimilar trastuzumab) reached a 44% market share in Japan last year.

Alvotech completes second round of private placement

March 15, 2021

Alvotech announced it has completed a second round of its US$100 million private placement.  In the first round, Alvotech raised US$65 million, including investments from Korea’s Shinhan, US’ Baxter Healthcare SA, and Germany’s ATHOS.

KR | Samsung Bioepis enters biosimilar adalimumab agreement with Yuhan

March 15, 2021

Korea Biomedical Review reported that Samsung Bioepis has entered an agreement with Yuhan Corp for the commercialisation of Adalloce™ (biosimilar adalimumab) in South Korea. Adalloce™ is marketed in Europe as Imraldi®.

US | US Senate passes two pieces of biosimilar legislation

March 14, 2021

The US Senate unanimously passed the Ensuring Innovation Act and the Advancing Education on Biosimilars Act.

The Ensuring Innovation Act aims to stop ‘evergreening’ by preventing pharmaceutical companies from claiming new innovations when they make insignificant modifications to their products. Under the current system, innovators are able to extend patent exclusivities by 5 years when one of these modifications is made.

The Advancing Education on Biosimilars Act aims to improve confidence in the safety and effectiveness of biosimilars by providing patients and providers with educational materials. These materials would include information about the standards for review and licensing of biosimilar products, relevant considerations for prescribers and the process of reporting adverse events for biological products. This material could be presented in webinars, videos, fact sheets and stakeholder toolkits.

US | Lannett provides update on insulin glargine biosimilar

March 10, 2021

Lannett announced it had received comments from the FDA related to the pivotal trial protocol and statistical analysis plan for its biosimilar insulin glargine program. Lannett said that it was comfortable with the feedback, and remains on track to submit an IND to the FDA later this calendar year. The pivotal trial is expected to commence in early 2022, with the BLA to be filed later in 2022 and launch expected in 2023.

Alteogen completes Ph I trials for ALT-L9 (biosimilar aflibercept)

March 5, 2021

Korea Biomedical Review reported that Alteogen has completed Ph I trials of ALT-L9 (proposed aflibercept biosimilar).

EMA publishes details of Celltrion’s Yuflyma® (biosimilar adalimumab)

March 3, 2021

The EMA published the EPAR for Celltrion’s Yuflyma®. The EPAR revealed that Celltrion’s product is citrate-free, but is not buffer-free, with other ingredients including ‘acetic acid, sodium acetate trihydrate, glycine, polysorbate 80 and water for injections’.

AU | NZ | Cipla expands biosimilar partnership with Alvotech for ANZ

March 2, 2021

Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).

AbbVie’s Humira® follow on Rinvoq® may face questions on class safety

March 1, 2021

Pharmaceutical Technology reported AbbVie’s intended Humira® follow on Rinvoq® (upadacitinib) may face questions on class safety after a safety signal emerged in a postmarketing trial of Pfizer’s Xeljanz® (tofacitinib). Tofacitinib and upadacitinib are both JAK inhibitors, and this safety signal could hamper the movement to JAK inhibitors.

Samsung Bioepis commenced Ph 1 trials for SB17 (proposed ustekinumab biosimilar)

March 1, 2021

Samsung Bioepis commenced Ph I trials for SB11 (proposed ustekinumab biosimilar).

EU | CHMP recommends listing Biocon’s Abevmy®(biosimilar bevacizumab)

March 1, 2021

Biocon and Viatris announced that the CHMP has adopted a positive opinion recommending the marking authorisation of Abevmy® (biosimilar bevacizumab). If approved, Abevmy® will be available for the treatment of metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer in 100mg and 400mg injections. The decision of the EC is expected in May 2021.

US | FDA expands the indications of Simponi Aria® (golimumab)

February 25, 2021

The FDA extended the indications of Simponi Aria® (golimumab) to include fatigue in patients with psoriatic arthritis and rheumatoid arthritis. This is the first TNF inhibitor approved to include fatigue improvement in its labeling.

US | Coherus reports Q420 and Full Year 2020 financial results

February 24, 2021

Coherus released its Q420 and Full Year 2020 financial results. Coherus reported it has captured 21% of the pegfilgrastim market and nearly 50% of the pre-filled syringe segment in the US. Additionally, Coherus announced it plans to file its BLA for its ranibizumab biosimilar mid-year 2021. Coherus also confirmed that it plans to launch its adalimumab biosimilar in the US on or after July 1, 2023.

US | Minnesota lawmakers push for greater access to biosimilars

February 24, 2021

Minnesota State Senator Carla Nelson (R-Rochester) and State Representative Jennifer Schultz (DFL-Duluth) announced the introduction of a new bill which would require health plans and pharmacy benefit managers to cover all versions of biosimilars.

AU | BR | EU | US | Fresenius Kabi announces it will launch its biosimilar adalimumab in Australia in Q2 2021

February 23, 2021

In its Q4 2020 investor presentation, Fresenius Kabi announced it will launch its biosimilar adalimumab in Australia in Q2 2021 and in Brazil in Q3 2021. Additionally, Fresenius Kabi announced it will launch its biosimilar pegfilgrastim in the US and the EU in Q3/4 2021. Fresenius Kabi’s biosimilar tocilizumab candidate is planned for launch in the US and the EU in 2023. An undisclosed autoimmune biosimilar is planned for a 2024 launch, and an oncology biosimilar in 2025.

CA | Viatris launches Hulio® (biosimilar adalimumab) in Canada

February 18, 2021

Viatris announced it has launched Hulio® (biosimilar adalimumab) in Canada. Hulio® is available in a 50mg/ml formulation (40mg/0.8mL) and is approved for all adalimumab indications.

CA | Fresenius Kabi launches Idacio® (biosimilar adalimumab) in Canada

February 18, 2021

Fresenius Kabi announced it has launched Idacio® (biosimilar adalimumab) in Canada. Idacio® is available in 50mg/ml formulation (40mg/0.8mL syringe, vial and pen presentations) and is approved for all Humira® indications.

CA | Sandoz launches Hyrimoz® (biosimilar adalimumab) in Canada

February 17, 2021

Sandoz announced that it has launched Hyrimoz®, its 50mg/mL biosimilar adalimumab in Canada. Hyrimoz® was approved by Health Canada in November 2020 with a full label. It was also previously launched in Europe in 2018.

US | FDA accepts Coherus’ BLA for biosimilar adalimumab

February 17, 2021

Coherus Biosciences announced the FDA has accepted the BLA for its biosimilar adalimumab candidate (CHS-1420). Coherus also announced that it plans to launch its product in the US on or after 01 July 2023. Coherus had previously disclosed that its license with AbbVie would commence in the US in December 2023.

JP | Fujifilm and Mylan launch Hulio® (biosimilar adalimumab) in Japan

February 15, 2021

Fujifilm Kyowa Kirin Biologics and Mylan announced the launch of Hulio® in Japan. Hulio® is available in a 40mg/0.8mL syringe and pen presentation (indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, ankylosing spondylitis, Entero-Behcet’s Disease and Crohn’s Disease), and a 20mg/0.4mL syringe (indicated for juvenile idiopathic arthritis). This is the first adalimumab biosimilar to be launched in Japan.

EU | Celltrion’s Yuflyma® (biosimilar adalimumab) approved in the EU

February 15, 2021

Celltrion announced it received EC marketing authorisation for Yuflyma® (biosimilar adalimumab) across all indications. This is the first approval of a high concentration, low-volume biosimilar adalimumab. The EPAR is yet to be published by EMA.

MENA | Tabuk partners with Prestige on Tuznue®(biosimilar trastuzumab)

February 13, 2021

Saudi Arabia’s Tabuk Pharmaceuticals announced it has reached an exclusive licensing and distribution agreement with Korea’s Prestige Biopharma for the commercialisation of Tuznue® (biosimilar trastuzumab). Under the agreement, Tabuk will receive exclusive rights to commercialise and distribute Tuznue® in the Middle-East and North Africa region.

EU | EU approves Biocon’s Kixelle®(biosimilar insulin aspart)

February 12, 2021

Biocon and Viatris announces Kixelle® (biosimilar insulin aspart) has received marking authorisation approval in the EU.

Roche releases Ph III results of follow-on faricimab

February 12, 2021

Roche announced new Ph III data shows faricimab (given at intervals of up to four months) is non-inferior compared to aflibercept (given every two months). This may reduce the treatment burden for patients suffering from diabetic macular edema and neovascular age-related macular degeneration.

Lannett and HEC reach insulin aspart agreement

February 9, 2021

Lannett announces it has entered into an agreement with the HEC Group of companies for biosimilar insulin aspart. Under the agreement, Lannett will be responsible for funding most of the clinical development requirements, while HEC will continue to develop the product and manufacturing infrastructure.

Celltrion commences Ph III aflibercept trials

February 8, 2021

Celltrion announces it has commenced Ph III trials of its proposed aflibercept biosimilar.

Roche reports huge erosion of YoY CER growth in key areas

February 4, 2021

Roche reports a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth of Avastin (bevacizumab) was -25%, with the hematology franchise (including rituximab) at -22% and HER2 franchise (including trastuzumab and pertuzumab) at -8%.

Celltrion discusses its adalimumab biosimilar

February 4, 2021

In an interview with the Centre for Biosimilars the head of Celltrion’s Medical and Marketing Division, HoUng Kim PhD, discussed its high concentration, citrate-free adalimumab biosimilar. Kim announced that Celltrion has completed patent settlements in the US and is approaching settlements in Europe. Kim also revealed that the application for Celltrion’s US biosimilar adalimumab product was filed in November 2020.

IN | Enzene Biosciences receives biosimilar teriparatide approval

February 4, 2021

Enzene Biosciences announces it has received marketing authorisation for its biosimilar teriparatide in India.

CA | US | Coherus Biosciences and Junshi Biosciences reach toripalimab agreement

February 1, 2021

Coherus Biosciences announces it has reached an agreement with Junshi Biosciences for the development and commercialisation of toripalimab (anti-PD-1 antibody) in the United States and Canada. Toripalimab has received breakthrough therapy designation by the FDA for nasopharyngeal carcinoma and the first BLA is expected to be filed later this year.

CA | Celltrion receives approval for biosimilar infliximab from Health Canada

February 1, 2021

Celltrion announces it has received a notice of compliance from Health Canada for Remsima® SC (subcutaneous infliximab). Remsima® has been approved for the treatment of rheumatoid arthritis.

EU | CHMP recommends 13 medicines for approval

January 29, 2021

The CHMP recommends13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience’s Alymsys® and STADA’s Oyavas®.

US | FDA accepts BLA for Bio-Thera’s biosimilar bevacizumab

January 28, 2021
Bio-Thera Solutions announces the FDA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).

US | Vizient releases Pharmacy Market Outlook

January 27, 2021

Health care performance improvement company Vizient releases its Winter 2021 Pharmacy Market Outlook. Vizient projected that the greatest price increases to members would occur in Humira® (adalimumab), with a 7.5% price increase predicted over the next 18 months. Adalimumab also topped the list of greatest total spend by product among Vizient members, followed by pembrolizumab, rituximab, infliximab, ustekinumab, nivolumab and denosumab. New figures also showed trastuzumab biosimilars have captured a significant market share, contributing to 39% of cost to members in September 2020.

Results of Ph I copanlisib and rituximab trials

January 20, 2021

Targeted Oncology interviews Mark J. Roschewski MD about the preliminary results of Ph II trials of copanlisib and rituximab as treatment of patients with untreated follicular lymphoma. Roschewski reported that all the patients responded and at least had a tumour reduction.

Pharm-Olam selected for adalimumab COVID-19 trial

January 19, 2021

Pharm-Olam announces it has been selected by the US Department of Defense to lead and provide full service clinical trial support of Ph II/III clinical trials of adalimumab as a COVID-19 therapeutic.

Innovent signs bevacizumab deal

January 18, 2021

Innovent announces it has signed a licensing agreement with PT Etana Biotechnologies for Byvasda® (biosimilar bevacizumab). Under the agreement, Etana will receive commercialisation rights in Indonesia in exchange for milestone payments and double-digit royalties on net sales.

Celltrion submits IND for denosumab biosimilar

January 15, 2021
Celltrion announces it has submitted an investigational new drug application for Ph III trials of CT-P41 (proposed denosumab biosimilar).

New study investigates use of rituximab in MS

January 8, 2021
A new study reviews the use of rituximab as an alternative treatment option for the management of multiple sclerosis (MS). While not approved for MS, there is evidence of significant off-label usage of rituximab for the treatment of MS in some Northern European countries.

EU | Strong uptake of Amgen’s Kanjinti® (biosimilar trastuzumab) in Europe

January 5, 2021
The Centre for Biosimilars reported a study presented at the 2020 San Antonio Breast Cancer Symposium found strong uptake of Amgen’s Kanjinti® (biosimilar trastuzumab) in Europe.

2020

CN | Innovent receives additional indication in China

December 27, 2020
Innovent announced China’s NMPA has approved Byvasda® (biosimilar bevacizumab) for the additional indication of adult recurrent glioblastoma.

FDA defers action on Biocon’s bevacizumab biosim

December 25, 2020
Biocon announces that it has been informed by the FDA of a deferred action on the BLA for its proposed bevacizumab biosimilar. This deferral was attributed to COVID-19, as the FDA was unable to conduct the required inspection of the manufacturing facility. Biocon is now awaiting dates for the inspection to occur.

Amgen’s Bourdon provides update on Riabni® (biosimilar rituximab) launch

December 24, 2020
The Centre for Biosimilars interviews Christophe Bourdon, senior VP and general manager of US Oncology at Amgen following FDA approval of Riabni® (biosimilar rituximab). Bourdon stated that Riabni® will be made available through speciality and wholesale distribution, and that Amgen is confident it will be able to support a quick uptake of this biosimilar.

Roche releases results of faricimab

December 23, 2020
Roche announces results for its investigational bispecific antibody faricimab in patients with diabetic macular edema. Roche announced that the candidate was generally well-tolerated with no new safety signals identified. This product is being developed as a replacement for Lucentis® (ranibizumab), which lost patent protection in the US this year.

BR | Bio-Thera Solutions licenses bevacizumab biosim in Brazil

December 21, 2020
Bio-Thera Solutions announces it has reached a licensing agreement with Biomm SA for BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Biomm will have exclusive rights to distribute and market the drug in Brazil. Bio-Thera has filed license applications for BAT1706 in the US, EU and China.

Celltrion provides ustekinumab update

December 21, 2020
Celltrion announces Ph III trials of its proposed ustekinumab biosimilar CT-P43 will be completed by the second half of 2022. Celltrion also announced plans to launch the product when the API patents expire in the EU in September 2023 and in the US in July 2024.

US | FDA approves Riabni®

December 17, 2020

Amgen announces it has received FDA approval for Riabni® (biosimilar rituximab) for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis and Microscopic Polyangiitis. Riabni® will be launched in the US in January 2021.

US | New study demonstrates increased usage of trastuzumab biosimilars

December 16, 2020

The Centre for Biosimilars reports a new study indicates dramatically increased usage of trastuzumab biosimilars in the US. The study presented at the San Antonio Breast Cancer Symposium indicated that biosimilar use increased based on payer policies that favored biosimilars.

Samsung commences Ph III denosumab trials

December 14, 2020

Samsung Bioepis announces it has commenced Ph III trials of SB16 (proposed denosumab biosimilar) in women with postmenopausal osteoporosis.

AstraZeneca to acquire Alexion

December 12, 2020

Biopharma supplier Alexion announces it will be acquired by AstraZeneca. The acquisition is expected to close in Q3 2021 for total consideration to Alexion shareholders of $39bn. Under the deal, AstraZeneca will acquire Alexion’s pipeline of 11 molecules, as well as Alexion’s blockbuster products Soliris® (eculizumab) and Ultomiris® (ravulizumab).

First patient dosed in Ph II trials of IBI310 and Tyvyt®

December 11, 2020

Innovent announces the first patient has been dosed in its Ph II trials of IBI310 (anti CTLA-4 monoclonal antibody) in combination with Tyvyt® (sintilimab) for the treatment of second-line or above advanced cervical cancer.

New study shows long-term biosimilarity of Truxima® to Rituxan®

December 11, 2020

A new long-term efficacy and safety study demonstrated the biosimilarity of Celltrion’s CT-P10/Truxima® (infliximab) to Rituxan® at 27 months in patients with low-tumor burden follicular lymphoma.

EU | Merck receives positive opinion from CHMP for pembrolizumab

December 10, 2020

Merck receives a positive opinion from the EU’s CHMP for an extended indication set for Keytruda® (pembrolizumab). If approved, Keytruda® will also be indicated for metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

EU | Celltrion receives positive opinion from CHMP for Yuflyma®(biosimilar adalimumab)

December 10, 2020

Celltrion receives a positive opinion from the EU’s CHMP for its proposed 100mg/mL adalimumab biosimilar Yuflyma® for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis. If approved, this will be the first registered high concentration, citrate-free adalimumab biosimilar anywhere in the world.

Intas Pharma’s Romy® demonstrates high overall response rate

December 9, 2020

A new study indicates Intas Pharma’s romiplostim biosimilar Romy® has demonstrated a high overall response rate without adverse events in patients with immune thrombocytopenic purpura. Romy® has been approved in India.

CN | China’s NMPA approves Henlius’ adalimumab

December 7, 2020

Shanghai Henlius Biotech announces its adalimumab biosimilar HLX03 has been approved by China’s NMPA for rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

US | Boehringer Ingelheim files Citizen Petition for interpretation

December 2, 2020

Boehringer Ingelheim filed a Citizen Petition asking the Commissioner of Food and Drugs to interpret the term ‘strength’ in s 351(k) of the PHS Act for parenteral solutions to mean ‘total drug content’. The current interpretation does not allow a biological product to be licensed as a biosimilar and/or interchangeable product if there is any variation in inactive drug volume. BI has argued that the proposed interpretation may increase access to more affordable biosimilar and interchangeable biological products.

US District Court refuses to award costs in pegfilgrastim dispute

December 1, 2020
US District Court Judge Leonard Stark refuses to grant costs in the Coherus/Amgen (pegfilgrastim) matter. Coherus argued that fees were warranted because Amgen had pursued a baseless claim and appeal, intending to thwart competition.

EU | Bio-Thera submits EU MA for bevacizumab

November 26, 2020

Bio-Thera Solutions announced it has submitted a marketing authorisation application for BAT1706 (proposed bevacizumab biosimilar) in EU.

EU | EU approves Tremfya® (guselkumab) for the treatment of psoriatic arthritis

November 25, 2020

Janssen announced that the European Commission has approved Tremfya® (guselkumab) for the treatment of adult patients with active psoriatic arthritis.

Novartis provides updates on Sandoz biosimilar candidates

November 24, 2020

Novartis released its annual report ‘Meet Novartis Management 2020‘. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis has also indicated it  has planned launches for biosimilar adalimumab and natalizumab in 2021-2023 and denosumab in 2024-2026.

CN | Alvotech and Yangtze River Pharmaceutical Group form strategic partnership

November 24, 2020

Alvotech and Alvotech & CCHT Biopharmaceutical announced they have partnered with Yangtze River Pharmaceutical Group to form an exclusive strategic partnership for the commercialisation of eight biosimilar medicines in China.  Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China, while Yangtze River Pharmaceutical will exclusively commercialise them.  The products will be manufactured in a new biopharmaceutical facility currently being built in Changchun, China through the Alvotech & CCHT partnership.

CA | Health Canada grants NOC for Hulio®

November 24, 2020

BGP Pharma receives a NOC from Health Canada for Hulio® (biosimilar adalimumab).

Innovent releases Ph III sintilimab and bevacizumab results

November 22, 2020

Innovent releases results of Ph III trials of Tyvyt® (sintilimab) with Byvasda® (biosimilar bevacizumab) as first-line treatment in patients with Advanced Hepatocellular Carcinoma (HCC).

Shanghai Henlius Biotech reports on Ph III bevacizumab trials

November 20, 2020
Shanghai Henlius Biotech reports positive results from Ph III trials of its biosimilar bevacizumab candidate.

Samsung Biologics and AstraZeneca abandon rituximab JV

November 19, 2020

Korean Biomedical Review reports Samsung Biologics and AstraZeneca will liquidate their joint venture Archigen Biotech and discontinue the development of SAIT101, a rituximab biosimilar. The project was discontinued due to a perceived lack of commercial viability.

EU | US | EMA and FDA accept Alvotech’s adalimumab application

November 19, 2020

Alvotech announces the FDA and EMA have accepted its regulatory submissions for AVT02 (proposed adalimumab biosimilar). Approval is expected in the US in September 2021 and Q4 2021 in the EU.

US | FDA accepts Samsung Bioepis and Biogen’s ranibizumab application

November 18, 2020

Samsung Bioepis and Biogen announce the FDA has accepted for review the BLA for SB11 (proposed ranibizumab biosimilar).

EU | EMA approves Nyvepria®

November 18, 2020

The EMA approved Pfizer’s Nyvepria® (biosimilar pegfilgrastim).

CSL’s Sequiris to build next-generation AU influenza vaccine manufacturing facility

November 16, 2020

CSL’s Sequiris announced it will build a next-generation $800 million influenza vaccine manufacturing facility in Australia. The facility is expected to be operational by mid-2026 and will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere.

US | Genentech sues Centus over bevacizumab biosimilar

November 15, 2020
Genentech files a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and Kyowa Kirin relating to its proposed bevacizumab biosimilar. Genentech asserts that Centus failed to provide sufficient information for Genentech to complete an analysis of potential patent infringements.

 

National Cabinet endorses national vaccination policy

November 13, 2020

PM Scott Morrison announced the National Cabinet has endorsed a national vaccination policy. The policy focusses on five key areas; R&D, purchase and manufacturing, international partnerships, regulation and safety and immunisation administration and monitoring.

EU | CHMP adopts positive opinion for Samsung Bioepis’ bevacizumab

November 12, 2020

The CHMP adopts a positive opinion for the marketing approval for Samsung Bioepis’ Onbevzi® (biosimilar bevacizumab). Onbevzi® will be available as a 25mg/mL concentrate for solution for infusion, and is indicated for the treatment of carcinoma or the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

AU | Celltrion’s Remsima® in auto-injection pen approved by TGA

November 12, 2020

The TGA approves Celltrion’s subcutaneous “biobetter” infliximab product Remsima® in auto-injection pen and PFS presentations. This is the first subcut infliximab product to be approved in Australia.

Samsung Bioepis announces one-year results of ranibizumab biosimilar

November 11, 2020

Samsung Bioepis announces one-year results from Ph III study of SB11 (proposed ranibizumab biosimilar) at the American Academy of Ophthalmology 2020 Virtual. Samsung reported the data confirms equivalence in efficacy and pharmocokinetics as well as a comparable safety and immunogenicity profile.

Prestige BioPharma and Teva Israel exclusive partnership and supply agreement for Prestige’s Tuznue®

November 10, 2020

Prestige BioPharma and Teva Israel announce they have entered into an exclusive partnership and supply agreement for Prestige’s Tuznue® (trastuzumab biosimilar) in Israel. Under the agreement, Prestige is responsible for registration and commercial supply, and Teva Israel will be responsible for local registration, sales and marketing in Israel.

Samsung Bioepis commences Ph I denosumab trials

November 10, 2020

Samsung Bioepis announced it has commenced Ph I trials for SB16 (proposed denosumab biosimilar).

Samsung Bioepis commences Ph I denosumab trials

November 10, 2020

Samsung Bioepis announces it has commenced Ph I trials for SB16 (proposed denosumab biosimilar).

Formycon and Bioeq commence Ph III trials of ustekinumab

November 9, 2020

Formycon and Bioeq announce they have commenced dosing in Ph III trials of FYB202 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

Shanghai Henlius Biotech commences Ph I denosumab trials

November 9, 2020

Shanghai Henlius Biotech announces it has commenced Ph I trials for HLX14 (proposed denosumab biosimilar).

Shanghai Henlius Biotech commences Ph I denosumab trials

November 9, 2020

Shanghai Henlius Biotech announces it has commenced Ph I trials for HLX14 (proposed denosumab biosimilar).

AU | CSL to commence manufacturing AZD1222

November 8, 2020

CSL confirmed it will commence manufacturing AZD1222 (AZ/Oxford vaccine) on 09 November 2020. The product will be manufactured at its facility in Broadmeadows, Victoria, in eight large scale batches over 2020-21.

Biocon Biologics approves capital injection from Goldman Sachs

November 7, 2020

Biocon Biologics announces it has approved a USD 150 million capital injection from Goldman Sachs. Dr Christiane Hamacher (CEO of Biocon Biologics) announced that this capital injection will enable Biocon Biologics to make prudent investments in R&D, high-quality manufacturing and establishing a global commercial footprint.

US | Formycon announces adjusted submission strategy for ranibizumab biosimilar

November 5, 2020

Formycon announces its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted. The approval will now be requested directly for a large commercial scale, which Formycon and Bioeq expect will simplify the approval procedure.

Agreement with AU Government, Novavax and Pfizer/BioNTech secures additional potential vaccine doses

November 5, 2020

The Australian Government announced it has secured an additional 50 million potential COVID-19 vaccine doses through agreements with Novavax and Pfizer/BioNTech.

ZA | Alvotech enters exclusive partnership with Cipla

November 4, 2020

Alvotech announces it has entered into an exclusive partnership with Cipla for two oncology biosimilars and three auto-immune biosimilars in South Africa. Under the agreement, Alvotech will be responsible for the development and supply of the products, while Cipla will be responsible for registration and commercialisation.

CA | Health Canada issues NOCs for Amgevita®

November 4, 2020

Amgen receives three Notices of Compliance (NOC) from Health Canada relating to Amgevita® (50mg/mL biosimilar adalimumab).

EU | Strides Pharma files EU teriparatide submission

November 3, 2020

Hindu Business Line reported Strides Pharma has filed a submission with the EMA for PTH® (proposed teriparatide biosimilar).

Australian Government close to securing supply contracts for additional proposed vaccines

November 2, 2020

SBS News reported Federal Health Minister Greg Hunt announced the Government is close to securing two supply contracts for an additional two proposed COVID-19 vaccines. Additionally, Minister Hunt announced that PM Scott Morrison will present a plan for vaccine rollout to National Cabinet in the coming weeks.

Celltrion announces results of Ph III trials of proposed AmAb biosimilar

November 2, 2020

Celltrion announces the results of Ph III studies of CT-P17 (proposed adalimumab biosimilar) demonstrate comparable efficacy and safety against reference adalimumab in rheumatoid arthritis.

Australian Government commits $500 million to supporting safe COVID-19 vaccines

October 31, 2020

Minister for Foreign Affairs Marise Payne announced the Australian Government has committed an additional $500 million over the next three years to supporting access to safe and effective COVID-19 vaccines for the Pacific and Southeast Asia region. This funding is additional to the $23.2 million committed in the Budget, the Government’s commitments to the COVAX facility and the existing Advance Purchase Agreements with Astra Zenexa-Oxford and CSL-University of Queensland.

CN | Ocumension Therapeutics reaches a development agreement with Shandong Boan Biological Technology

October 30, 2020

Ocumension Therapeutics announces it has reached an agreement with Shandong Boan Biological Technology to jointly develop OT-702, a proposed aflibercept biosimilar. Under the agreement, Ocumension has been granted an exclusive license to promote and commercialise the product in mainland China. OT-702 is currently in Ph III trials.

CN | Ocumension Therapeutics announces agreement with Shandong Boan Biological Technology to develop aflibercept

October 30, 2020

Ocumension Therapeutics announces it has reached an agreement with Shandong Boan Biological Technology to jointly develop OT-702, a proposed aflibercept biosimilar. Under the agreement, Ocumension has been granted an exclusive license to promote and commercialise the product in mainland China. OT-702 is currently in Ph III trials.

CA | Health Canada issues NOC for Idacio®

October 30, 2020

Fresenius Kabi receives a Notice of Compliance relating to its biosimilar adalimumab (50mg/mL), Idacio®.

SomaLogic signs agreement with FDA for large-scale analysis of proteins

October 29, 2020

SomaLogic announces it has signed an agreement with the FDA for the large-scale analysis of proteins for the identification of biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar and a reference product. It is hoped that the five year collaboration will streamline the development of biosimilars by reducing the need for comparative clinical studies, thus accelerating the delivery of safe, effective and affordable biosimilar treatments.

Amgen releases Q3 2020 financial results

October 28, 2020

In its Q3 2020 financial results, Amgen announces that it is moving ABP 654 (proposed ustekinumab biosimilar) into Ph III development.

Alvotech Holdings SA completes private placement round

October 27, 2020

Alvotech announces that its parent company, Alvotech Holdings SA, has successfully completed a $65 million private placement round, which will further finance the development and release of its biosimilar candidates. This $65 million round is part of a larger $100 million round, with a second round expected to close shortly. The new share issue values Alvotech at $1.5 billion.

Results from post-marketing studies of Renflexis® released by Samsung Bioepis

October 26, 2020

Samsung Bioepis announces results from two post-marketing studies of Renflexis® (biosimilar infliximab) in Veteran Affairs patients with IBD. The first study evaluated the safety of switching from reference infliximab to Renflexis®, finding that patients who were on reference product or biosimilar infliximab can remain stable after switching to another biosimilar without major safety concerns. The second study looked at utilisation patterns of infliximab for IBD, finding that the uptake of Samsung Bioepis’ Renflexis® (following its listing as the preferred product on the Veterans Affairs National Formulary Policy) was faster than the adoption of the previous biosimilar listed in the year prior.

Industry Minister announces expected 12 month development period of COVID-19 vaccine

October 25, 2020

Industry Minister Karen Andrews announced it could take up to 12 months to roll out a COVID-19 vaccine, if the successful candidate is not protein-based. Andrews explained that while CSL has a lot of experience in producing protein-based vaccines, mRNA vaccines have never been successfully manufactured and distributed.

US | AstraZeneca resumes US clinical trials following FD authorisation

October 23, 2020

AstraZeneca announced it has resumed clinical trials in the US following authorisation from the FDA. The trials have now fully resumed globally.

Ph III clinical trials of FYB202 commence

October 20, 2020

Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commence recruiting in Poland.

NeuClone announces Ph I clinical trials ustekinumab biosimilar results

October 20, 2020

NeuClone announces its proposed ustekinumab biosimilar has successfully met all primary and secondary endpoints in Ph I clinical trials. Noelle Sundstrom, CEO of NeuClone announced that the company plans to enter Ph III trials in 2021. The product is being jointly developed by NeuClone and the Serum Institute of India.

Results from new study on Celltrion’s rituximab biosimilar CT-P10 released

October 20, 2020

The American Journal of Managed Care reported a new study indicates Celltrion’s rituximab biosimilar CT-P10 could lower costs and expand patient access to biologic therapy for primary Sjogren syndrome.

EG | Sandoz Egypt partners with the Egyptian Cancer Society

October 20, 2020

Daily News Egypt announces Sandoz Egypt has partnered with the Egyptian Cancer Society to launch a rituximab biosimilar in Egypt. Sameh Elbagoury, Sandoz Country Head for Sandoz Egypt and Libya, announced that the biosimilar could reduce the cost of treating Non-Hodgkin Lymphoma by 40%.

Polpharma publishes ustekinumab biosimilar is under development

October 16, 2020

Polpharma publishes ustekinumab biosimilar is under development.

EU | CHMP recommends Tremfya® (guselkumab) for the treatment of psoriatic arthritis

October 16, 2020

Janssen announced that the CHMP has adopted a positive opinion recommending the expanded use of Tremfya® (guselkumab) to include the treatment of adult patients with active psoriatic arthritis.

All | Henlius and Essex enter co-development and exclusive license agreement for HLX04

October 15, 2020

Henlius and Essex announce they have entered into a co-development and exclusive license agreement for HLX04 (proposed bevacizumab biosimilar). Under the agreement, Essex will be granted an exclusive license to develop, manufacture and commercialise HLX04 globally. Essex will be responsible for 80% of the costs and expenses in relation to the development of HLX04. Henlius is entitled to milestone payments of up to US$43 million, as well as royalties of up to 10% of annual net sales of the product.

BR | Celltrio signs contract to provide Herzuma® and Truxima® to Brazilian Federal Government

October 13, 2020

Korea Biomedical Review reports Celltrion has signed a contract to provide Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab) to the Brazilian Federal Government. Celltrion has also signed a contract to provide Truxima® to the Sao Paulo Provincial Government.

Results from Centre for Biosimilars studies for HD201 released

October 13, 2020

The Centre for Biosimilars reports two new studies for HD201 (Prestige Biopharma’s proposed trastuzumab biosimilar) were presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology. The first study, TROIKA-I demonstrated that HD201 was safe and well tolerated with PK comparability to the originator. The second, TROIKA was designed to compare safety, PK and efficacy based on the total pathological complete response rate. The investigators reported that the studies demonstrated equivalence between the biosimilar and reference products.

US | Two amicus briefs filed in support of Humira® antitrust legislation

October 12, 2020

Two amicus briefs were filed in the 7th Circuit Court of Appeals in support of the plaintiffs in the Humira® (adalimumab) antitrust legislation UFCW Local 1500 Welfare Fund v AbbVie, Inc. The US Public Interest Research Group jointly filed its brief with Consumer Action, arguing that AbbVie’s conduct was anticompetitive, and that the District Court’s decision should be overturned. In its brief, the Open Markets Institute argued that the District Court should have evaluated AbbVie’s patent applications and lawsuits as a series of sham filings.

Celltrion presents interim results at the UEG Week Virtual 2020

October 10, 2020

Celltrion presents positive interim results from Ph I trials of CT-P13 of subcutaneous Remsima® (biosimilar infliximab) in IBD at the UEG Week Virtual 2020. The results indicated that subcutaneous infliximab may be associated with better clinical outcomes compared to intravenous infliximab.

CN | China’s NMPA grants marketing approval for Halpryza®

October 9, 2020

Innovent and Eli Lilly jointly announce China’s NMPA has granted marketing approval for Halpryza® (biosimilar rituximab). Halpryza® is indicated for the treatment of patients with diffuse large b cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia.

Celltrion recieves approval for Ph III trials of CT-P39

October 8, 2020

Korea Biomedical Review reports Celltrion has received approval for Ph III trials of CT-P39 (proposed omalizumab biosimilar).

Australian Government acknowledges damage in annual 2020 budget caused by vaccine uncertainty

October 7, 2020

In its annual 2020 budget, the Australian Government acknowledged the damage to Australia’s economy caused by vaccine uncertainty.  The Government also pledged $23.2 million over the next three years to the COVID-19 Vaccine Access and Health Security Program to support the development of national immunisation policies in Pacific and Southeast Asian countries.  A further $304.7 million has been pledged for additional recovery support for Pacific Island countries and Timor-Leste.

EU | Samsung Bioepis and Biogen Marketing Authorisation Application reviewed

October 6, 2020

Samsung Bioepis and Biogen announce the European Medicines Agency has accepted for review its Marketing Authorisation Application for SB11 (proposed ranibizumab biosimilar).

Study approves of Sandoz’s Zarxio® as treatment of cancer

October 6, 2020

Onco’Zine reports a new study released by the American Society of Clinical Oncology Quality Care Symposium indicates that Sandoz’s Zarxio® (biosimilar filgrastim) is not only safe and effective, but is cost effective in treating chemotherapy-induced febrile neutropenia in early-stage breast cancer patients.

CA | EU | US | Medicure enters License, Manufacture and Supply Agreement with Reliance Life Sciences

October 5, 2020

Medicure announces it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences for a cardiovascular biosimilar product for EU, US and Canada. Medicure is responsible for the regulatory approval process for that product.

AU | Lupin biosimilar etanercept Etera® and Rymti® approved

October 1, 2020

Lupin receives approval for biosimilar etanercept in Australia under the trade names Etera® and Rymti® in PFS presentations.

Oxford commences Ph II AmAb trials in COVID-19 patients

September 30, 2020

The University of Oxford announces it has commenced Ph II trials of adalimumab as a treatment for patients with COVID-19. The trial will enrol up to 750 patients from community care settings throughout the UK and is funded by the COVID-19 Therapeutics Accelerator, an initiative set up by Wellcome and Mastercard. The trial will assess Hyrimoz® (biosimilar adalimumab), developed by Sandoz.

EU | Centus Biotherapeutics announces EC marketing authorisation for Equidacent®

September 29, 2020

Centus Biotherapeutics announces it has received EC marketing authorisation for Equidacent® (biosimilar bevacizumab). Equidacent® has been exclusively licensed to Fujifilm Kyowa Kirin Biologics on a worldwide basis.

Innovent announces Ph III trial update

September 28, 2020

Innovent announces its ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt® (sintilimab) met its primary endpoints of progression-free survival and overall survival. Innovent reported that the safety profile of both products was consistent with previously reported studies, and no new safety signals were identified.

UK | Accord Healthcare launches Zercepac® in UK

September 24, 2020

Accord Healthcare launches Zercepac® (biosimilar trastuzumab) in the UK. Zercepac® is indicated for HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer and is available in a 150mg single-dose vial.

Australian Government joins COVAX facility

September 23, 2020

The Australian Government announced it has joined the COVAX facility, committing an initial $123.2 million for the ability to purchase vaccines when they become available. The COVAX facility is a collaboration between Gavi, the Coalition for Epidemic Preparedness Innovations, the WHO and other organisations and aims to ensure equitable access to COVID-19 vaccines.

JP | Dong-A ST receives sales approval for biosimilar darbepoetin in Japan

September 23, 2020

Dong-A ST announces sales approval for biosimilar darbepoetin from Japan’s Ministry of Health, Labour and Welfare. 

BD | HK | ID | IN | KH | KR | MY | PH | PK | SG | TH | TW | VN | Alvotech expands strategic partnership with DKSH for biosimilar product commercialisation

September 22, 2020

Alvotech announces an expansion of its strategic partnership with DKSH to commercialise six new biosimilar product candidates for Asian markets, including Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan. These biosimilar candidates’ brand values are estimated around US$1.5 billion in annual sales in the Asia Pacific region, according to IQVIA data.. The biosimilar candidates will address multiple therapeutic areas and represent an estimated (combined) US$1.5 billion in annual sales in the Asia Pacific region.

AU | Australian Government commits $6 million to research and development of potential vaccines

September 20, 2020

SBS News reported the Australian Government has committed $6 million to the research and development of three potential COVID-19 vaccines. The University of Melbourne will receive $3 million for the development of two vaccines, and the University of Sydney will receive $3 million to commence clinical trials of a novel DNA-based COVID-19 vaccine.

Regenxbio commences dosing in Ph II trials

September 20, 2020

Regenxbio announces it has commenced dosing in Ph II trials comparing RGX-314 to monthly ranibizumab injections. RGX-314 is being developed as a novel, one-time subretinal treatment for wet AMD and diabetic retinopathy.

The Centre for Biosimilars reports data demonstrates positive findings for Ph I trials of HD201

September 17, 2020

The Centre for Biosimilars reports that data presented at the ESMO Virtual Congress by PrestigeBiopharma demonstrates positive findings for Ph I trials of HD201 (proposed bevacizumab biosimilar). HD201 is current under review by the EMA.

TH | TW | VN | Lotus Pharma and Chong Kun Dang announce darbepoetin deal

September 17, 2020

Lotus Pharma announces it has signed a commercialisation agreement with Chong Kun Dang for Nesbell® (biosimilar darbepoetin-alpha). Under the agreement, Chong Kun Dang will supply Lotus with Nesbell® for sale in Taiwan, Vietnam and Thailand pending the success of clinical trials in those countries.

CA | Merck announces Health Canada approval of Brenzys® for indications

September 15, 2020

Merck announced Health Canada has approved Brenzys® (biosimilar etanercept) for four new indications:

  • adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

  • pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy

  • reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis and improving physical function in adult patients with psoriatic arthritis (PsA)

  • reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years

BR | UK | AstraZeneca resumes clinical trials following MHRA confirmation

September 12, 2020

AstraZeneca announced it has resumed clinical trials in the UK and Brazil following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.

Congress of Clinical Rheumatology East presents results from new study on ustekinumab

September 10, 2020

A new study presented at the Congress of Clinical Rheumatology East indicates that ustekinumab is safe and efficacious in young and elderly patients with psoriatic arthritis. Researchers reported that there were no clinically meaningful differences in the effectiveness and safety in PsA patients 60 years or older compared with those younger than 60.

New study demonstrates efficacy of natalizumab in MS

September 10, 2020

Neurology Advisor reported a new study indicates that natalizumab may be more effective than fingolimod or BRACETD in reducing relapses in patients with relapsing-remitting multiple sclerosis.

AstraZeneca voluntarily pauses Ph III trials of AZD1222 for investigation

September 9, 2020

AstraZeneca announced it has voluntarily paused Ph III trials of AZD1222 to investigate a potentially unexplained illness in one of the trials. AZ said it will expedite the review of the single event to minimise any impact to the trial timeline.

AU | CSL announces it will supply the AU Government with doses of UQ vaccine candidate

September 6, 2020

CSL announced it will supply the Australian Government with 51 million doses of UQ’s vaccine candidate UQ-CSL V451 if proven successful. The first tranche of doses is expected to be available by mid-2021, with additional doses expected in late 2021 and early 2022. The vaccine candidate is currently in Ph I trials.

Bio-Thera Solutions commences clinical trials of BAT2206

September 3, 2020

Bio-Thera Solutions commences dosing in Ph I clinical trials of BAT2206 (proposed ustekinumab biosimilar).

Lupus Foundation of Australia reports results from study on rituximab

September 3, 2020

Lupus Foundation of Australia reports a new study demonstrates that rituximab may prove effective as a treatment option for refractory lupus. The study was conducted in 147 people with lupus, and found that six months after the first treatment, 45% of patients demonstrated a complete response to therapy, with another 28% demonstrated some improvement in disease activity.

Targeted Oncology reports results of Ph III trial of Samsung Bioepis’ SB8

September 3, 2020

Targeted Oncology reports the results of a Ph III trial of Samsung Bioepis’ proposed bevacizumab biosimilar, SB8. The researchers reported that the objective response rate ratio of SB8 and bevacizumab appeared equivalent, with comparable safety, pharmacokinetics and immunogenicity as a treatment of patients with metastatic or recurrent nonsquamous non-small cell lung cancer.

CN | China’s NMPA approves Sulinno®

September 3, 2020

Innovent Biologics announces China’s NMPA has approved Sulinno® for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.

Results from study of Amgen/Allergan’s proposed rituximab biosimilar released

September 1, 2020

A new study examining the analytical and functional similarity of Amgen/Allergan’s proposed rituximab biosimilar ABP798 concludes that it is highly analytically similar to Rituxan®.

NeuClone working on nivolumab biosimilar

September 1, 2020

NeuClone Pharmaceuticals disclosed it is working on biosimilars referencing Opdivo® (nivolumab) and Keytruda® (pembrolizumab).  The products are in the advanced stages of pre-clinical development and are being developed in partnership with the Serum Institute of India.

Xbrane intentions to file application for Xlucane® reported

September 1, 2020

Generics update reports Xbrane is aiming to file an application for Xlucane® (biosimilar ranibizumab) in Europe and the US, and to license the product in Latin America, Japan and China in the next 12 months.

NeuClone Pharmaceuticals discloses potential biosimilar pembrolizumab

September 1, 2020

NeuClone Pharmaceuticals discloses it is working on a biosimilar referencing Keytruda® (pembrolizumab). The product is in the advanced stages of pre-clinical development and is being developed in partnership with the Serum Institute of India.

AstraZeneca commences Ph III trials of AZD1222

August 31, 2020

AstraZeneca announced it has commenced Ph III trials of AZD1222. Up to 30,000 adults in the US will be recruited, with testing sites also in Peru, Chile, UK, Brazil and South Africa. The results of the trial are anticipated later this year.

Results of UK Kings College/NHS Trust MERLOT trial reported

August 28, 2020

Healio reports the results of the UK Kings College/NHS Trust MERLOT trial demonstrated there was no benefit to epimacular brachytherapy as an adjunct to anti-VEGF injections, the results of which were worse than ranibizumab monotherapy, for the treatment of neovascular age-related macular degeneration.

IN | Cadila launches Cadalimab® in India

August 28, 2020

Cadila Pharmaceuticals launches Cadalimab® (biosimilar adalimumab) in India. Cadalimab® is available in 40mg/0.8mL injection and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis. This is the fourth biosimilar launch in India by Cadila within 2 months following Bevaro® (biosimilar bevacizumab), Ritucad® (biosimilar rituximab) and NuPTH® (biosimilar teriparatide).

New denosumab study demonstrates correlation between delayed injections and osteoporotic fractures

August 27, 2020

Rheumatology Advisor reports a study sponsored by China’s National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation demonstrates that delayed administration of subsequent denosumab doses by greater than 16 weeks is associated with increased risk for vertebral fracture. This risk was observed in both the short delay (4-16 weeks) and the long delay (>16 weeks) groups. Additionally, there was a significant correlation between delayed subsequent injections and major osteoporotic fractures.

Multiple Sclerosis News Today reports results from study on Ocrevus®

August 26, 2020

Multiple Sclerosis News Today reports a new real-life study demonstrates that Ocrevus® (ocrelizumab) carries a higher risk of infections but carries a lower risk of cancer and immune reactions than rituximab in patients with multiple sclerosis.

DE | Lupin and Mylan launch Nepexto® in Germany

August 26, 2020

Lupin and Mylan launch Nepexto® (biosimilar etanercept) in Germany. Nepexto® is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, severe axial spondyloarthritis and plaque psoriasis.

CN | HK | MO | TW | Bio-Thera Solutions and BeiGene announce executed agreement

August 24, 2020

Bio-Thera Solutions and BeiGene announce they have executed a license / distribution and supply agreement for BAT1706 (proposed bevacizumab biosimilar). Subject to approval by Bio-Thera’s shareholders in September, the agreement grants BeiGene the right to develop, manufacture and commercialise BAT1706 in mainland China, Hong Kong, Macau and Taiwan in return for milestone payments totalling US$165M, and tiered double-digit royalties on future net product sales.

JP | Merck announces additional approvals for Keytruda®

August 24, 2020

Merck announces Keytruda® (pembrolizumab) has received two additional approvals from the Japanese Pharmaceuticals and Medical Devices Agency:

  • new indication for the treatment of patients whose tumours are PD-L1-positive, and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma;

  • and an additional dosage regimen of 400mg every six weeks as an IV infusion over 30 minutes, across all adult indications.

AU | Pfizer application to PBS recommended

August 21, 2020

Pfizer’s application to PBS list its biosimilar bevacizumab (Zirabev®) under the same conditions as Avastin® was recommended.

AU | PBAC adopts positive recommendation for expanded Hadlima® indications

August 21, 2020

PBS publishes the outcomes of the July 2020 meeting including a positive recommendation for Merck’s application to broaden out the PBS reimbursed indications for its Hadlima® (biosimilar adalimumab). Merck’s Hadlima® was first granted PBS listing in 2018 for rheumatoid arthritis only. The expanded recommendation follows Sandoz’s positive recommendation for Hyrimoz® earlier this year, which included the same indications as Humira®.

Intract Pharma and Celltrion sign development agreement

August 20, 2020

Intract Pharma and Celltrion announce an agreement to jointly develop the world’s first oral antibody therapeutic for the treatment of IBD. The infliximab product has been cleared by the UK’s MHRA to proceed to Ph 1b/2a clinical trials in patients with IBD during the second half of 2021.

EU | Samsung Bioepis announces EC has granted marketing authorisation for Aybintio®

August 20, 2020

Samsung Bioepis announces that the EC has granted marketing authorisation for Aybintio®, biosimilar bevacizumab (Avastin®) with a full indication set. EMA accepted Samsung’s application on 19 July 2019, and CHMP positive opinion was granted on 26 June 2020. This is Samsung’s 5th approved EU biosimilar, and the 3rd approved biosimilar to bevacizumab (following the approval of Amgen/Allergan’s Mvasti® in January 2018 and Pfizer’s Zirabev® in December 2018). Centus Biotherapeutics’ application for Equidacent® follows Samsung’s closely, having received CHMP positive opinion in July 2020.

CA | Sandoz Canada enters agreement with pCPA regarding Ziextenzo® and Riximyo®

August 19, 2020

Sandoz Canada announces it has entered an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) regarding biosimilar medicines Ziextenzo® (biosimilar pegfilgrastim) and Riximyo® (biosimilar rituximab). Both products were approved by Health Canada in late April 2020. Under the pCPA agreement, Riximyo® is reimbursed in Ontario (from July 2020) for certain indications, through Cancer Care Ontario. Additionally, British Columbia announced the reimbursement of Riximyo® (from August 2020) through BC Cancer.

AU | Australian Government signs a Letter of Intent with AstraZeneca for supply of vaccine candidate

August 19, 2020

The Prime Minister’s office announced the Australian Government has signed a Letter of Intent with AstraZeneca for the supply of the University of Oxford’s COVID-19 vaccine candidate AZD1222. If trials prove successful, safe and effective, it is expected that every Australian will have access to the free vaccine.

Results from Ph III trials of Keytruda® released

August 19, 2020

Merck announces the results of Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy for first-line treatment of patients with locally advanced or metastatic esophageal cancer. Merck reported that Keytruda® met the primary and secondary endpoints and that the safety profile was consistent with that observed in previously reported studies.

CA | Sandoz Canada enters agreement with pCPA for Ziextenzo® and Riximyo®

August 19, 2020

Sandoz Canada announces it has entered an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) regarding biosimilar medicines Ziextenzo® (biosimilar pegfilgrastim) and Riximyo® (biosimilar rituximab). Both products were approved by Health Canada in late April 2020. 

AU | CSL confirms prioritised development of UQ vaccine candidate

August 18, 2020

CSL confirmed the development of the University of Queensland’s (UQ) vaccine candidate remains its priority. CSL also disclosed that it has entered discussions with AstraZeneca and the Australian Government to assess whether it can provide local manufacturing support for the Oxford University/AZ vaccine should it prove successful.

CN | Shanghai Henlius Biotech trastuzumab biosimilar Zercepac® approved

August 14, 2020

Shanghai Henlius Biotech announces China’s NMPA has approved its trastuzumab biosimilar Zercepac®. Zercepac® is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

US | Celltrion refutes claims of study on Remsima® and Remicade®

August 14, 2020

The Centre for Biosimilars reports that Celltrion has refuted the claims of a July 2020 study which critiqued the methods used by Celltrion and the FDA to determine whether Remsima® (biosimilar infliximab) was equivalent to Remicade®. Among its critiques of the study, Celltrion has argued that the study does not reflect the FDA review procedure and the principles of the regulatory guidelines.

Celltrion announces Ph I denosumab trials to commence in September 2020

August 14, 2020

Korea Biomedical Review reports that Celltrion will commence Ph I clinical trials of CT-P41 (biosimilar denosumab candidate) in September.

US | Polpharm’s plans to file modified application reported

August 11, 2020

The Centre for Biosimilars reports that Polpharma is planning to file a modified application for FYB201 (biosimilar ranibizumab candidate) to the FDA within the next year.

Janssen’s golimumab Simponi® under safety surveillance

August 11, 2020

Docwirenews reports a new post-approval safety surveillance study of Janssen’s golimumab Simponi® demonstrated that there is no association between exposure to golimumab and an increased risk of prespecified outcomes.

BR | Samsung Bioepis launches Ontruzant®

August 10, 2020

Samsung Bioepis launches Ontruzant® (biosimilar trastuzumab) in Brazil. Ontruzant® is indicated for the treatment of metastatic HER2-overexpressing breast cancer, early HER2-overexpressing breast cancer, and advanced gastric cancer.

AVEO reports data from Ph I study of ficlatuzumab and cetuximab

August 10, 2020

AVEO Oncology releases its Q2 FY2020 earnings report. AVEO reported data from its Ph I study of ficlatuzumab and cetuximab in patients with advanced head and neck squamous cell carcinoma (HNSCC) demonstrated that the products have an acceptable safety profile and showed promising anti-tumour activity in a refractory HNSCC patient population. AVEO also announced that it is evaluating the process to secure additional clinical manufacturing of ficlatuzumab to potentially enable a Ph III clinical trial in 2022.

New study indicates ixekizumab demonstrates greater joint and skin improvement than adalimumab

August 10, 2020

Healio reports a new article published in the Annals of the Rheumatic Diseases showed that ixekizumab demonstrated significantly greater joint and skin improvement than adalimumab among patients with psoriatic arthritis (PsA). The 52 week SPIRIT trial assessed 566 adults with PsA who had not yet been treated with a biological disease-modifying anti-rheumatic drugs.

Findings from Sandoz’s REFLECT study of SDX-RTX released

August 7, 2020

OncLive publishes an interview with Manfred Welslau, MD on the findings from the interim results of Sandoz’s REFLECT study of SDX-RTX (rituximab biosimilar). These results reconfirmed the safety and efficacy profile of the product, which has already been approved in the EU, Switzerland, Japan, New Zealand and Australia. Welslau announced that the full results of this study will be released at the end of 2020 or the beginning of 2021.

US | Celltrion’s Q2 FY20 earnings report is released

August 7, 2020

Celltrion releases its Q2 FY20 earnings report. Celltrion reported that Remsima SC® remains in Ph III clinical trials in the US.

US | Celltrion preparing US AmAb application

August 7, 2020

Celltrion releases its Q2 FY20 earnings report.  Celltrion reported that it is “preparing” its US approval application for CT-P17 (biosimilar adalimumab candidate), following the filing of its application in the EU in March this year. 

US | Alvotech and Teva strategic collaboration partnership for biosimilar products

August 5, 2020

Alvotech and Teva announce a strategic partnership to collaborate on five biosimilar product candidates in the US market. Under the agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, while Teva will be exclusively commercialising the products in the US. The agreement includes an upfront payment, with subsequent milestone payments, with Alvotech and Teva to share the profits from commercialisation.

Celltrion trastuzumab biosimilar Herzuma® gains WHO prequalification

August 3, 2020

Celltrion gains WHO prequalification for its trastuzumab biosimilar Herzuma®. The prequalification status enables Celltrion to make a bid in global procurement by UN agencies, and is based on an evaluation of safety and efficacy.

US | FDA approves additional indication for Janssen Stelara®

July 30, 2020

Janssen announces the FDA approved an additional indication for Stelara® (ustekinumab) for paediatric patients with skin lesions or moderate to severe plaque psoriasis.

IN | Cadila Pharmaceuticals launches Ritucad®

July 29, 2020

Cadila Pharmaceuticals announces it has launched Ritucad® (biosimilar rituximab). Ritucad® has been approved for Non-Hodgkin’s Lymphoma and rheumatoid arthritis. This follows Cadila’s launch of Bevaro® (biosimilar bevacizumab) in India last week.

EU | Shanghai Henlius Biotech and Accord Healthcare announce EC approval of Zercepac®

July 29, 2020

Shanghai Henlius Biotech and Accord Healthcare jointly announce the European Commission has approved Zercepac® (biosimilar trastuzumab) for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

Pfizer Q2 FY20 financial results released

July 28, 2020

Pfizer releases its Q2 FY20 financial results. Pfizer reported a 16% decrease in international revenues for Enbrel® (etanercept), attributing this decrease to biosimilar competition in Europe, Japan and Brazil. 

US | Pfizer Q2 FY20 financial results released

July 28, 2020

Pfizer releases its Q2 FY20 financial results. Pfizer reveals that it plans to launch Nyvepria® (biosimilar pegfilgrastim) in the US later this year.

EU | European Commission grants marketing authorisation for Remsima®

July 27, 2020

Celltrion announces the European Commission has granted marketing authorisation for Remsima® (biosimilar infliximab) subcutaneous formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.

Study reports comparability of Cyltezo® and Humira®

July 27, 2020

The Centre for Biosimilars reports a study presented at the American Academy of Dermatology’s Virtual Meeting Experience 2020 demonstrates the safety, efficacy and immunogenicity of Boehringer Ingelheim’s Cyltezo® (biosimilar adalimumab) is comparable to AbbVie’s Humira®.

Results of study into Sandoz’s Ziextenzo® released

July 24, 2020

A new study published by the Journal of Clinical Pathways demonstrates significant cost-savings generated by Sandoz’s pegfilgrastim biosimilar Ziextenzo®.

EU | The CHMP recommends marketing authorisation for Equidacent®

July 23, 2020

The CHMP adopts a positive opinion recommending the granting of marketing authorisation for Centus Biotherapeutics’ Equidacent® (biosimilar bevacizumab) for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and carcinoma of the cervix.

IN | Cadila Pharma announces launch of Bevaro® in India

July 22, 2020

Cadila Pharma announces it has launched Bevaro® (biosimilar bevacizumab) in India. Bevaro® s indicated for ovarian cancer, glioblastoma, colorectal cancer, breast cancer, lung cancer, cervical cancer and kidney cancer.

Genentech Ph III Archway study results released

July 22, 2020

Genentech publishes the results from its Ph III Archway study, evaluating its Port Delivery System (PDS) with ranibizumab for the treatment of neovascular age-related macular degeneration (nAMD).  Genentech reported that 98.4% of patients were able to go six months without requiring additional treatment, and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections.

Novartis Q2 FY20 financial results released

July 21, 2020

Novartis releases its Q2 FY20 financial results, reporting COVID-19 negatively impacted demand for Lucentis® (ranibizumab).

AstraZeneca Ph I/II trial interim results released

July 20, 2020

AstraZeneca announced interim results from ongoing Ph I/II trial showed AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.

EU | Humira® sales negatively impacted by prescription of alternative mechanism of action agents

July 20, 2020

Spherix reports that the EU market for AbbVie’s Humira® has been negatively impacted by gastroenterologists increasingly prescribing alternative mechanism of action agents, including Stelara® (ustekinumab) and Entyvio® (vedolizumab) for ulcerative colitis (UC) and Crohn’s disease (CD) and the increased prescription of adalimumab biosimilars. These increases have come at a cost to AbbVie, with use of Humira® in UC and CD decreasing in the EU.

MY | VentureTECH, Duopharma and PanGen Biotech announce development joint venture

July 17, 2020

VentureTECH, Duopharma and PanGen Biotech announce a joint venture to develop a Malaysian biosimilar production facility.

RU | Bio-Thera Solutions enters BAT2506 licensing agreement with Pharmapark

July 17, 2020

Bio-Thera Solutions annnounces a licensing agreement with Pharmapark for BAT2506 (biosimilar golimumab candidate). Under the agreement, Pharmapark will have exclusive rights to distribute and market the drug in Russia and other CIS countries.

CA | Sandoz anticipates launch of pegfilgrastim and rituximab

July 17, 2020

In an interview with Generics update, Sandoz Canada announces it is aiming for 10 biosimilar launches in the next decade, with pegfilgrastim and rituximab to be launched shortly.

RU | Bio-Thera Solutions’ licensing agreement with Pharmapark

July 17, 2020

Bio-Thera Solutions annnounces a licensing agreement with Pharmapark for BAT2506 (biosimilar golimumab candidate). Under the agreement, Pharmapark will have exclusive rights to distribute and market the drug in Russia and other CIS countries.

Results of Phase I and III trials of omalizumab candidate reported

July 15, 2020

In an interview with the Centre for Biosimilars, Celltrion’s head of marketing, Byoungseo Choi reports Phase I and III trials of Celltrion’s omalizumab candidate are ongoing, and are expected to conclude by 2022.

Centre of Biosimilars reports the potential of Remsima® as COVID-19 treatment

July 15, 2020

In an interview with the Centre for Biosimilars, Celltrion’s head of marketing, Byoungseo Choi reports Remsima® (biosimilar infliximab) is showing promise as a potential treatment for COVID-19.

Celltrion reports that Ph III trials for CT-P16 are set to commence

July 15, 2020

In an interview with the Centre for Biosimilars, Celltrion’s head of marketing, Byoungseo Choi reports that Phase III trials for CT-P16 (proposed biosimilar bevacizumab) are set to commence, with EU submission planned for next year.

CSL Ph I trials of proposed COVID-19 vaccine commence

July 13, 2020

CSL announced it has commenced Ph I trials of its proposed COVID-19 vaccine. The clinical batch of vaccine for use in the trial has been manufactured by the UQ and CSIRO, with technical assistance from CSL and Cytiva.

US | FDA approves Hulio®

July 9, 2020

Mylan announces FDA approval of Hulio® (biosimilar adalimumab) for PFS and auto-injector presentations.

Results from study on Herzuma® released by Journal of Clinical Pathways

July 8, 2020

The Journal of Clinical Pathways report a new study shows a triplet regimen of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy is effective in patients with HER-2 positive advanced gastric cancer.

US | Genentech and Amgen file stipulations for dismissal of BPCIA litigation

July 7, 2020

Genentech and Amgen file stipulations in the US District Court of Delaware dismissing their BPCIA litigation relating to trastuzumab and bevacizumab biosimilars. This comes after the Court of Appeals refused to block Amgen’s Mvasi® from entering US markets on July 06.

Outlook Therapeutics completes patient enrolment for NORSE 2 clinical trials

July 7, 2020

Outlook Therapeutics announces it has completed patient enrolment for its NORSE 2 clinical trials of Lytenava® (proposed bevacizumab biosimilar).

US | Sandoz responds to US Court of Appeals judgement upholding judgement of Amgen etanercept patents valid

July 1, 2020

Sandoz responds to the US Court of Appeals judgment which upheld a ruling from the New Jersey District Court which declared the Amgen patents relating to (etanercept) valid. Sandoz stated that it will continue its efforts to make Erelzi® available in the US, and is evaluating its options, including a possible appeal to the US Supreme Court.

US | US District Court of Delaware’s rejection of Amgen

July 1, 2020

The US District Court of Delaware refuses to combine Amgen’s two actions against Pfizer and Hospira relating to filgrastim. The original action was filed in July 2018, and the more recent action was filed in April 2020. In the oral order, (available courtesy of Goodwin), the Court ruled that as Amgen would not agree to use the same experts for both cases, they should bear the consequences of litigating an action nearly two years after the original action. The Court also indicated that it would entertain Pfizer/Hospira’s proposed motion to stay the second action.

CN | BeiGene launches Xgeva® in China

June 30, 2020

BeiGene announces its has begun commercialising Xgeva® (denosumab) in China. Xgeva® was developed by Amgen, and is the first of the products to be commercialised by BeiGene under a January 2020 agreement.

AU | Amgen receives Australian approval for Mvasi® as Avastin®

June 30, 2020

Amgen receives Australian approval for Mvasi® (biosimilar bevacizumab) for all indications as Avastin®.

Samsung Bioepis announces commencement of Ph III trials of aflibercept

June 30, 2020

Samsung Bioepis announces it has commenced Ph III trials of SB15, proposed aflibercept biosimilar.

US | Genentech files complaint against Samsung Bioepis alleging infringements

June 30, 2020

Genentech files a complaint against Samsung Bioepis in the District Court of Delaware under the BPCIA, alleging infringement of 14 patents related to SB8 (Samsung’s proposed bevacizumab biosimilar), and violation of the “patent dance” provisions.

EU | Celltrion announces EU’s CHMP recommendations for additional indications of subcut Remsima®

June 29, 2020

Celltrion announces EU’s CHMP recommended expanding the marketing authorisation for its subcut Remsima® (biosimilar infliximab) to include the following additional indications: IBD, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis. This extends the indications beyond RA which was approved in November 2019.

US | FDA approves Keytruda®

June 29, 2020

Merck announces the FDA has approved Keytruda® (pembrolizumab) for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

JP | Fujifilm receives AmAb manufacturing and marketing approval in Japan

June 29, 2020

Fujifilm Kyowa Kirin Biologics announces manufacturing and marketing approval in Japan for FKB237 (adalimumab biosimilar). This product was developed in partnership with Mylan and has been marketed as Hulio® in 20 countries across Europe.

US | Dr Reddy’s Ph III trials progress and anticipates launch

June 28, 2020

Outlook India reports Dr Reddy’s is expecting to launch 25 products in the US market in the current financial year and that Dr Reddy’s Ph III trials of a proposed rituximab biosimilar are progressing as planned.

Janssen discontinues Ph III LOTUS study of Stelara®

June 26, 2020

Janssen announces it has discontinued its Ph III LOTUS study of Stelara® (ustekinumab) in Systematic Lupus Erythematosus due to lack of efficacy.

EU | Samsung Bioepis announces CHMP’s positive apinion for Aybintio®

June 26, 2020

Samsung Bioepis announces the CHMP has adopted a positive opinion for Aybintio® (biosimilar bevacizumab).

AbbVie and Sosei Heptares deal to discover and develop immunology drugs

June 25, 2020

AbbVie and Sosei Heptares announce a $409M deal to discover and develop new immunology drugs.  The agreement covers the drug-discovery, development and commercialisation of small-molecule medicines that target autoimmune and inflammatory diseases using the G protein-coupled receptor.  AbbVie will pay Sosei Heptares up to $32M upfront and at milestones for an additional $377M, along with royalties.

EU | JP | US | Aptevo Therapeutics announces fixed royalty payments from Pfizer for Ruxience® launch

June 25, 2020

Aptevo Therapeutics announces it will receive quarterly “low single digit” fixed royalty payments from Pfizer (Wyeth) for 7 years from the first launch of Ruxience® (biosimilar rituximab). The original royalty agreement was signed by Trubion Pharmaceuticals which was then acquired by Aptevo’s spin-off Emergent BioSolutions, and Wyeth, in 2016. The royalty is applied to net sales in the US, EU and Japan.

Ankylosing Spondylitis News’ approval of Simponi®

June 22, 2020

Ankylosing Spondylitis News reports new data from Germany indicates Simponi® (golimumab) is an effective therapy for people with ankylosing spondylitis and other chronic inflammatory conditions, regardless of pre-treatment with other TNF inhibitors.

CN | Bio-Thera Solutions announces China’s NMPA has accepted BLA for BAT1706

June 19, 2020

Bio-Thera Solutions announces China’s NMPA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).

CN | Innovent Biologics announces China’s NMPA has approved Byvasda®

June 19, 2020

Innovent Biologics announces China’s NMPA has approved Byvasda® (bevacizumab) for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China.

AU | TGA approves Idacio®

June 17, 2020

Fresenius Kabi receives Australian approval for Idacio® (biosimilar adalimumab) with identical indications as Humira®, in 40mg vial, PFS and pen.

Henlius Biotech announces results of Ph III trials of HLX04

June 16, 2020

Henlius Biotech announces the results of Ph III trials of HLX04 (proposed bevacizumab biosimilar) in combination with oxaliplatin and fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer. Henlius reports that the study successfully met the primary endpoint.

Samsung Bioepis announces approval to commence global trial of aflibercept

June 15, 2020

Samsung Bioepis announces it has received approval to commence a global Ph III trial of SB15 (proposed aflibercept biosimilar) in patients with age-related macular degeneration.

Results from Celltrion Phase II trials of Truxima® released

June 14, 2020

Celltrion presents new data from Phase II trials of a Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib regime for the treatment of relapsed/refractory aggressive B-cell lymphoma. Celltrion reports that the regime was well tolerated by patients.

AU | HK | KR | SG | TH | TW | Celltrion enters deal to acquire Takeda Pharmaceuticals Primary Care businesses

June 11, 2020

Celltrion announces a $278 million deal to acquire Takeda Pharmaceuticals Primary Care businesses in the Asia Pacific. Under the agreement, Celltrion will gain access to patent, trademark and marketing rights for 18 prescription and over-the-counter brands in 9 markets including South Korea, Thailand, Taiwan, Hong Kong, Singapore and Australia.

US | FDA approves Pfizer’s Nyvepria®

June 11, 2020

Pfizer announces the FDA has approved Nyvepria® (pegfilgrastim). Nyvepria® is indicated to decrease the incidence of infection, manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Hetero releases results of AmAb trials

June 11, 2020

A new study published in BMC Rheumatology reports that Hetero’s biosimilar adalimumab Mabura® was effective and well tolerated in comparison to Humira® in patients with active rheumatoid arthritis.

Celltrion’s infliximab biosimilar CT-P13 announced as trial of CATALYST Study

June 10, 2020

The University of Oxford announces Celltrion’s infliximab biosimilar CT-P13 (Inflectra®, Remsima®) would be one of the products trialled in the CATALYST Study. This study is examining possible treatments for patients with COVID-19. It is hoped that the CT-P13 will prevent the immune system response which leads to cytokine storm syndrome in COVID patients.

CA | Health Canada grants marketing approval for Ziextenzo® and Riximyo®

June 9, 2020

Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

CA | Sandoz granted marketing approval for Ziextenzo® and Riximyo®

June 9, 2020

Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

US | US District Court rules AbbVie’s conduct was not illegal, but prevented competition

June 9, 2020

The Big Molecule Watch reports that a US District Court Judge ruled AbbVie’s conduct in relation to its blockbuster Humira® (adalimumab), while preventing competitors from reaching the market in the US, was not illegal. The action was filed against AbbVie by a number of parties including the City of Baltimore and a pension for Police Officers, and alleges that by amassing a ‘patent thicket’ and settling litigation with competitors which prevented them launching in the US, AbbVie had engaged in conduct which breached federal and state antitrust laws.

Coalition for Epidemic Preparedness Innovations, CSL and University of QLD enter partnering agreement

June 5, 2020

The Coalition for Epidemic Preparedness Innovations, CSL and the University of Queensland announced they have entered into a partnering agreement to accelerate the development, manufacture and distribution of a COVID-19 vaccine candidate.

EU | Mylan and Lupin Nepexto® receives EMA marketing authorisation

June 4, 2020

Mylan and Lupin announce EMA marketing authorisation for Nepexto® (etanercept) for all indications of the reference product Enbrel®.

US | Bloomberg Law reports on ongoing dispute between Genentech and Amgen

June 4, 2020

Bloomberg Law reports on the ongoing US Court of Appeals for the Federal Circuit dispute between Genentech and Amgen regarding bevacizumab. In a hearing on 3 June 2020, Genentech asked the Court to prevent Amgen selling its biosimilar bevacizumab Mvasi® to new patients, despite the trial Court refusing to prevent Amgen’s launch, and the US Court of Appeals refusing to injunct Amgen early in the appeal. Decision reserved.

US | FDA approves Taltz® (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis

June 1, 2020

Eli Lilly announced that the FDA has approved Taltz® (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis.

EU | CHMP recommends marketing authorisation for Henlius Biotech HLX02

May 31, 2020

Henlius Biotech announces it has received a positive CHMP opinion, recommending marketing authorisation for HLX02 (proposed trastuzumab biosimilar).

Alexion and Amgen announce eculizumab settlement

May 29, 2020

In a filing to the Securities and Exchange Commission, Alexion announces it has settled its eculizumab dispute with Amgen. Under the agreement, Amgen will receive a non-exclusive, royalty-free license to market its product from 01 March 2025.

DE | Fresenius Kabi and Medac reach AmAb deal

May 29, 2020

Fresenius Kabi announces it has signed an agreement with Medac to cooperate in Germany in the area of treatments for rheumatic illnesses. From 01 June 2020, Medac’s sales representatives will be able to offer Fresenius Kabi’s adalimumab biosimilar Idacio. Medac is already a provider of methotrexate, a product which is often used in combination with adalimumab.

Celltrion’s Truxima® certified in WHO prequalification program

May 28, 2020

The WHO certifies Celltrion’s Truxima® (rituximab) in its prequalification program. This program assesses clinical and other data related to biosimilars, and aims to guide low-income countries in their selection of medicines, vaccines and technologies for national procurement.

CN | Henlius Biotech adalimumab and trastuzumab under New Drug Application review

May 27, 2020

Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.

China’s NMPA approves Henlius’ IND

May 27, 2020

Shanghai Henlius Biotech announces that China’s National Medical Products Administration has approved its IND application for HLX14, a proposed denosumab biosimilar. 

US | FDA accepts Fresenius Kabi BLA

May 27, 2020

Fresenius Kabi announces that the FDA has accepted its BLA for MSB 11455, a proposed pegfilgrastim biosimilar.

CN | Shanghai Henlius Biotech’s AmAb under NDA review in China

May 27, 2020

Shanghai Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.

US | The American Journal of Managed Care report released

May 26, 2020

The American Journal of Managed Care reports two cost savings studies presented at a virtual meeting of the International Society for Pharmacoeconomics and Outcomes Research. The studies, which were sponsored by Pfizer, analysed the potential cost savings over a three year period from a US perspective in switching to bevacizumab and rituximab biosimilars. The studies concluded that over three years $14.7 million could be saved on bevacizumab used to treat 503-676 patients, with $3.8 million saved on rituximab used to treat 754-764 patients.

EU | Mylan Q1 earnings call released by JD Supra

May 22, 2020

JD Supra reports on Mylan’s Q1 earnings call. In the call, Mylan announced its partner Biocon had received FDA pre-approval of its Malaysian manufacturing facility, as well as announcing a planned launch for Nepexto® (etanercept) in Europe within months.

Mylan announced that BLA and marketing authorisation under review by FDA and European authorities, biosimilar insulin and aflibercept projects remain on target

May 22, 2020

JD Supra reports on Mylan’s Q1 earnings call. In the call, Mylan announced that the BLA and marketing authorisation for its bevacizumab candidate is currently under review by the FDA and European authorities. Mylan also confirmed that its biosimilar insulin and aflibercept projects remain on target.

JHL Biotech commences dosing in Ph I denosumab trials

May 18, 2020

JHL Biotech announces that the first group of subjects in the Australian randomised Ph I trials of JHL1266 (proposed denosumab) have been dosed.

Samsung Bioepis Ph III trial results of SB11 released

May 18, 2020

Samsung Bioepis announces 24-week interim results from a Ph III trial of SB11 (a proposed ranibizumab biosimilar) in patients with neovascular age-related macular degeneration. Samsung Bioepis announced that the primary endpoints of the trial were met, suggesting that SB11 will be a valuable treatment option for nAMD.

Formycon update on biosimilar portfolio

May 15, 2020

Formycon releases an update on its biosimilar portfolio. Ph III clinical trials for a proposed ustekinumab biosimilar are scheduled to commence in Q3 2020.

Results from Samsung Bioepis study on Ontruzant® released

May 15, 2020

Samsung Bioepis announces the results of a four year follow up study of Ontruzant® (trastuzumab) will be presented at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO) at the end of this month. The study assessed the cardiac safety and surival outcome in a subgroup of patients from the Ph III study.

Update on Formycon biosimilar portfolio released

May 15, 2020

Formycon releases an update on its biosimilar portfolio. In the statement, Formycon confirmed it is continuing to work with license partner Bioeq on a resubmission of the BLA for FYB201 (proposed ranibizumab biosimilar).

Formycon announces aflibercept is proceeding as expected

May 15, 2020

Formycon releases an update on its biosimilar portfolio, announcing its biosimilar aflibercept candidate is proceeding as expected, with Ph III clinical trials expected to begin mid-2020.

Biocon manufacturing practice compliance recognised

May 12, 2020

Biocon receives good manufacturing practice compliance certificate from the EMA for Bengaluru facilities.

Alvotech announces results of Ph I and III AmAb trials

May 12, 2020

Alvotech releases the results of two studies for AVT02, a proposed adalimumab biosimilar, announcing both studies met their primary endpoints. Alvotech announced that the Ph I clinical study demonstrated the PK similarity of AVT02 to the reference product Humira®, while the Ph III study demonstrated equivalent efficacy compared to Humira® in patients with moderate-to-severe chronic plaque psoriasis.

Novartis reports on adalimumab and secukinumab comparison study

May 8, 2020

Results of the Novartis’ EXCEED study comparing adalimumab and secukinumab for the treatment of PSA (psoriatic arthritis) were released.  Researchers reported no statistically significant superiority between secukinumab and adalimumab as first-line treatment of psoriatic arthritis, but secukinumab was associated with a higher treatment retention rate than adalimumab.

AbbVie completes acquisition of Allergan

May 8, 2020

AbbVie announces it has completed its acquisition of Allergan, following regulatory approval from all relevant Government agencies. AbbVie will now have access to Allergan’s neuroscience products including Vraylar® and Ubrelvy®, and aesthetic products including the Botox® and Juvederm® brands.

The American Journal of Medical Care publishes results of clinical trials

May 8, 2020

The American Journal of Medical Care publishes results of clinical trials of AryoGen’s BE1040V, biosimilar bevacizumab. Researchers reported the product was non-inferior to the reference product in terms of efficacy for the treatment of metastatic colorectal cancer.

Bausch + Lomb enter exclusive licensing agreement

May 6, 2020

Bausch + Lomb announce it has entered into an exclusive licensing agreement with STADA and Xbrane Biopharma for the development and commercialisation of a ranibizumab biosimilar. Under the agreement, Xbrane and STADA will be jointly responsible for finalising development of the biosimilar, with Xbrane to provide commercial supply and Bausch + Lomb responsible for sales, marketing and all other commercialisation efforts.

US | Teva and Celltrion announce launch of Truxima®

May 4, 2020

Teva and Celltrion announce the launch of Truxima® in the US. Truxima® is indicated for the treatment of rheumatoid arthritis, granulomatosis with polyangiitis and miscroscopic polyangiitis, making it the only approved biosimilar with the same indications as Rituxan®.

AbbVie reports decline in global Humira® sales

May 1, 2020

AbbVie released its Q1 2020 financial results, reporting a 13.7% increase in US sales of Humira® from Q1 2019. In global markets, Humira® sales were down 14.9%, a decline that was attributed to biosimilar competition.

US | Amgen files suit against Hospira and Pfizer

May 1, 2020

Amgen filed suit against Hospira and Pfizer, alleging infringement of US patent 10,577,392, relating to the manufacture of Neupogen®. Interestingly, the patent was only granted on March 03, 2020, nearly 2 years after Hospira launched Nivestym®.

AstraZeneca and University of Oxford agreement for global development and distribution

April 30, 2020

AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of a potential recombinant adenovirus vaccine.

Gedeon Richter enters asset purchase agreement with Mycenax Biotech

April 29, 2020

Gedeon Richter announces it has entered an asset purchase agreement with Mycenax Biotech for the purchase of a biosimilar tocilizumab product. Under the agreement, Richter will receive worldwide rights to develop, manufacture and commercialise the product which is expected to reach global markets in 2025.

CA | Fulphila® launched by Mylan and Biocon in Canada

April 28, 2020

Mylan and Biocon launch Fulphila® (pegfilgrastim) in Canada. Fulphila® is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

US | J&J files supplemental marketing applications

April 24, 2020

J&J announces it has filed two supplemental marketing applications for Simponi Aria (golimumab) with the FDA. J&J have applied for the additional indications of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients at least two years old.

EU | Henlius Biotech receives EU GMP certificates for trastuzumab biosimilar

April 23, 2020

Henlius Biotech announces it has received two EU GMP certificates related to its trastuzumab biosimilar HLX02.

US | Merck and Samsung Bioepis Ontruzant® launches in the US

April 15, 2020

Merck and Samsung Bioepis launch Ontruzant® (trastuzumab) in the US. Ontruzant® is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative breast cancer as part of a treatment regimen and as a single agent following multi-modality anthracycline based therapy.

AU | Mylan and Biocon launch Fulphila® in Australia

April 14, 2020

Mylan and Biocon launch Fulphila® (pegfilgrastim) in Australia. Fulphila® is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections.

NeuClone Pharma announces progress for Ph I trials of NeuLara

April 8, 2020

NeuClone Pharma announces it has completed monitoring visits and blood sampling for Ph I trials of NeuLara.

FDA approves encorafenib/cetuximab combination

April 8, 2020

Pfizer announces the FDA has approved Braftovi® (encorafenib) in combination with Erbitux® (cetuximab) for the treatment of BRAF600E-mutant metastatic colorectal cancer after prior therapy.

EU | EC approves of Ruxience® for treatment

April 2, 2020

Pfizer announces EC approval of Ruxience® for the treatment of non-hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

Xbrane continues clinical trials of ranibizumab candidate

April 2, 2020

Xbrane announces it is continuing clinical trials of its ranibizumab candidate and remained on-track for target dates for regulatory filings despite CoVid-19.

UK | Filing errors ruled in a Supplementary Protection Certificate for Lucentis®

March 31, 2020

The UK High Court rules filing errors in a Supplementary Protection Certificate (SPC) for Lucentis® (ranibizumab) have cut almost two years from Roche/Genentech’s protection in the UK. These errors arose when a third party engaged by Roche/Genentech failed to pay the full lump sum fees at the start of the SPC term.

US | FDA approves Taltz® (ixekizumab) for the treatment of paediatric patients with plaque psoriasis

March 30, 2020

Eli Lilly announced that the FDA has approved Taltz® (ixekizumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis.

BA | Biocad receives registration certificates for Acellbia® and Herticad®

March 30, 2020

Biocad announces it has received registration certificates from Bosnia and Herzegovina for Acellbia® (rituximab) and Herticad® (trastuzumab), with a launch expected in 2020.

Results of Ph 1 trials of BP001 released

March 30, 2020

BiosanaPharma releases the results of Ph I trials of BP001 (omalizumab), reporting comparability to Xolair®.

Genentech announces extended physician payment terms for Lucentis®

March 30, 2020

Genentech announces that in response to CoVid-19, it would extend physician payment terms for Lucentis® (ranibizumab) purchases to 120 days, up from the previous 60 day term. These new terms will be implemented from 01 April, 2020, as well as retroactively for Lucentis® purchased on or after March 1, 2020.

EU | EU’s CHMP recommends Mylan and Lupin Nepexto® for indications

March 27, 2020

Mylan and Lupin announce the EU’s CHMP has adopted a positive opinion recommending Nepexto® (etanercept) for all indications as Enbrel®.

JP | Janssen announces additional indication for Stelara® approved

March 26, 2020

Janssen announces approval of additional indication of ulcerative colitis for Stelara® (ustekinumab) in Japan.

iBio and AzarGen Biotechnologies enter second Statement of Work

March 26, 2020

iBio and AzarGen Biotechnologies announce they have entered into a second Statement of Work under their Master Joint Development Agreement. Under this agreement, iBio will assist AzarGen in the manufacture and characterisation of supplies to enable pre-clinical studies of a rituximab biosimilar.

Alvotech and DKSH announce AmAb deal

March 24, 2020

Alvotech and DKSH announce an exclusive license partnership for the commercialisation of AVT02 (adalimumab candidate) in 36 emerging countries in South-East Asia. Under the agreement, Alvotech will be responsible for development and supply and DKSH will be responsible for registration and commercialisation.

US | FDA approves Samsung Bioepis mutli-dose vial Ontruzant®

March 24, 2020

Samsung Bioepis announces the FDA has approved its 420mg multi-dose vial of Ontruzant® (trastuzumab).

Results of study on Truxima® released

March 17, 2020

A new study reports that Truxima®  is comparable to the originator in terms of efficacy and safety in the treatment of multiple sclerosis.

US | Teva and Celltrion launch Herzuma®

March 16, 2020

Teva and Celltrion launch Herzuma® (trastuzumab) in the US. Herzuma® is indicated for the treatment of breast cancer, metastatic breast cancer and metastatic gastric cancer.

CN | J&J announces Dano® indication

March 14, 2020

J&J announces Dano® is now also indicated for the treatment of adults with moderate to severe Crohn’s Disease. 

Hisun completes Ph III AmAb trials

March 12, 2020

Hisun Pharmaceuticals completes Phase III trials of HS016 (adalimumab). Researchers concluded that HS016 was similar to adalimumab in terms efficacy and safety in the treatment of ankylosing spondylitis.

EU | Celltrion submits AmAb application in the EU

March 9, 2020

Celltrion submits its application for CT-P17 (adalimumab) to the EMA. If approved, CT-P17 will be the first high-concentration adalimumab available.

US | Refusal of Amgen preliminary injunct for biosimilar trastuzumab affirmed

March 9, 2020

The US Federal Court of Appeals for the Circuit Court affirms the lower court’s refusal to preliminary injunct Amgen for its sale of biosimilar trastuzumab. Trial is expected to begin on 20 April, 2020.

CN | China’s NMPA accepts Henlius’ denosumab NDA

March 9, 2020

Shanghai Henlius Biotech announces China’s National Medical Administration had accepted its Investigational New Drug application for HLX14 (denosumab). HLX14 is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

US | Mylan announces FDA accepted aBLA for proposed bevacizumab biosimilar

March 6, 2020

In its 2019 Q4 earnings call, Mylan announces the FDA has accepted its aBLA for a proposed bevacizumab biosimilar. The FDA’s decision is expected on or before December 27, 2020.

US | AbbVie outlines defence strategy for Humira® competition

February 18, 2020

AbbVie outlines defence strategy for Humira® (adalimumab) competition in the US market. CEO Gonzalez stated that AbbVie’s strategy will be based on the strategy already employed in Europe and other markets, while also admitting that global competition was much more aggressive than had been predicted.

EU | Pfizer delays Amsparity® launch in EU

February 13, 2020

Despite receiving CHMP approval earlier this month, Pfizer has announced it does not currently plan to launch Amsparity® (adalimumab) in the EU, citing unfavourable market conditions. 

US | Amgen sues Hospira for proposed pegfilgrastim biosimilar

February 11, 2020

Amgen sues Hospira in the District Court of Delaware, alleging Hospira’s aBLA for a proposed pegfilgrastim biosimilar infringes Amgen’s Neulasta patent for protein purification (no. 8,273,707).​

Bio-Thera announces BAT1706 met endpoint in Ph III clinical trials

February 3, 2020

Bio-Thera announces BAT1706 (bevacizumab candidate) met the primary endpoint in Ph III clinical trials.

EU | CHMP releases opinion for Ruxience®

January 31, 2020

Pfizer announces positive CHMP opinion for Ruxience® .

CA | Health Canada approves additional indication for Stelara®

January 27, 2020

Health Canada approves ulcerative colitis as an additional indication for Stelara®.

US | Pfizer launches Ruxience®

January 23, 2020

Pfizer launches Ruxience® in the US at a 24% discount to Rituxan®.

US | Pfizer anticipates biosimilar TmAb Trazimera® launch

January 23, 2020

Pfizer announces biosimilar TmAb Trazimera® will launch in the US on 15 February at a 22% discount to Herceptin.

UK | UK’s NICE discourages Stelara®

January 22, 2020

The UK’s NICE announces it will not recommend Stelara® for moderately to severely active ulcerative colitis due to uncertainties over cost-effectiveness.

US | AbbVie warns of Humira® profit erosion in 2023

January 21, 2020

AbbVie management acknowledge losses will be felt when biosimilar adalimumab products launch in the US market in 2023. Drawing from an international profit erosion of 45-48% for Humira® in 2019, AbbVie’s CEO Gonzalez warned stakeholders that biosimilar competition in the US would further impact profits. Gonzalez also noted that the erosion rate in the US would not be directly comparable to European markets as it would be heavily impacted by negotiations with managed care and pharmacy benefit managers.

Ph III clinical trials of ranibizumab Port Delivery System commence

January 17, 2020

Genentech and Roche commence Ph III clinical trials of ranibizumab Port Delivery System (PDS) in patients with diabetic macular edema. The PDS uses a refillable eye implant to release a ranibizumab formulation over several months.

US | Health New England announces savings through utilisation of biosimilar infliximab

January 16, 2020

Health New England, a nonprofit health plan in Massachusetts, announces savings of $1.7 million in the past year by reaching 93% utilisation of biosimilar infliximab.

CA | Alvotech and JAMP enter biosimilar commercialisation agreement

January 15, 2020

Alvotech and JAMP announce agreement to commercialise five biosimilar products in Canada.

HK | TW | Mundipharma and Samsung announce AmAb deal

January 13, 2020

Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung’s adalimumab candidate in Taiwan and Hong Kong.

HK | TW | Mundipharma enters exclusive commercialisation agreement with Samsung

January 13, 2020

Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung’s adalimumab, etanercept, trastuzumab and bevacizumab candidates in Taiwan and Hong Kong.

US | Coherus acquires commercialisation rights to rituximab biosimilar

January 13, 2020

Coherus exercises option under agreement with Innovent to acquire commercialisation rights to rituximab biosimilar in the US.

US | Coherus announces licensing agreement with Innovent

January 13, 2020

Coherus announces licensing agreement with Innovent for the commercialisation of Innovent’s bevacizumab candidate, with plans to file an aBLA in late 2020 or early 2021.

Clover dosing in Ph III trials of etanercept commences

January 11, 2020

Clover announces it has commenced dosing in Ph III trials of etanercept.

CN | Bio-Thera launches Qletli® in China

January 10, 2020

Bio-Thera launches adalimumab biosimilar, Qletli® in China following Nov 2019 approval.

CN | Samsung and AffaMed announce approval for Ph III eculizumab trials

January 10, 2020

Samsung and AffaMed announce Chinese approval for Phase III trials of eculizumab candidate.

US | US Court of Appeals affirms invalidity of three Humira® patents

January 7, 2020

US Court of Appeals affirms US PTAB’s earlier decision, which invalidated three AbbVie patents (8,889,135, 9,017,680 and 9,073,987) as obvious. The initial challenges to these patents were brought by Coherus and Boehringer Ingelheim, who have since settled with AbbVie, leaving the appeal to be defended by the USPTO.

US | Pfizer launches bevacizumab biosimilar Zirabev®

January 7, 2020

Pfizer launches bevacizumab biosimilar Zirabev® in the US, at a 23% discount to Avastin®.

CN | Mabpharm submits a New Drug Application

January 6, 2020

Sorrento Therapeutics announces partner Mabpharm has submitted a New Drug Application for its biosimilar infliximab to the Chinese NMPA.

New study of Pfizer’s Nivestim® against Neupogen®

January 3, 2020

New study demonstrates noninferiority of Pfizer’s Nivestim® to reference Neupogen®. Additionally, the study demonstrated that those in the biosimilar group reported a shorter median hospitalisation period by two days.

Clover receives approval for clinical trials in China

January 2, 2020

Clover announces it has received approved to enter clinical trials in China with SCB-808, biosimilar etanercept.

2019

US | Amgen submits BLA to FDA

December 19, 2019

Amgen submits BLA for biosimilar rituximab to FDA. 

US | Amgen and Tanvex’s dismissal in filgrastim dispute

December 19, 2019

Amgen and Tanvex file a joint stipulation of dismissal in their filgrastim dispute. The stipulation of dismissal states that parties will bear their own costs and attorney’s fees.

NeuClone announces completion of patient recruitment and dosing in Ph I trials of biosimilar ustekinumab

December 18, 2019

NeuClone announces completion of patient recruitment and dosing in Ph I trials of ustekinumab biosimilar.

CN | Qilu receives Chinese approval for bevacizumab biosimilar, Ankada®

December 17, 2019

Qilu receives Chinese approval for its bevacizumab biosimilar, Ankada®. 

Dong-A Socio Holdings and Meiji Seika announce commencement of Ph I trials of biosimilar ustekinumab

December 16, 2019

Dong-A Socio Holdings and Meiji Seika announce commencement of Ph I trials of ustekinumab biosimilar.

EU | Lupin Ph III trials of etanercept biosimilar results released

December 16, 2019

Lupin releases results of Ph III trials of etanercept biosimilar, reporting similarity with the reference product.

EU | CHMP recommends approval of Amsparity®

December 13, 2019

Pfizer receives positive CHMP opinion for its biosimilar adalimumab product.

Boehringer announces results of Ph III trials of AmAb

December 13, 2019

Boehringer Ingelheim has released the results of its Ph III trials of its biosimilar adalimumab, announcing the product demonstrated non-inferior efficacy and similar safety profile to the originator.

CA | Study on savings with Apotex’s Grastofil®

December 13, 2019

A new study released by the Universities of Saskatchewan and Alberta reveal substantial savings for health services switching to Apotex’s Grastofil®. The study analysed Canadian sales between 2016 and 2018, finding that the biosimilar accounted for $13,443,873 in savings, but could have accounted for $36,348,476 in savings had it been used in 100% of cases.

CN | AffaMed Ph III trials of Samsung’s trastuzumab biosimilar approved

December 10, 2019

AffaMed receives Chinese approval to commence Ph III trials of Samsung’s trastuzumab biosimilar SB3.

Celltrion Ph III trials of Truxima® released

December 9, 2019

Celltrion releases results of Ph III trials of Truxima® at the American Society of Hematology, announcing it was non inferior to Rituxan® in terms of efficacy and safety.

Results of NeuClone Ph I trials of trastuzumab biosimilar released

December 5, 2019

NeuClone announces results of Ph I trials of trastuzumab biosimilar, reporting the product successfully met primary and secondary endpoints.

CN | Bio-Thera announces NMPA approval to commence Ph I trials of biosimilar ustekinumab

December 4, 2019

Bio-Thera announces NMPA approval to commence Ph I trials of ustekinumab biosimilar.

Outcome based agreement for Enbrel® announced by Amgen and Abarca

December 4, 2019

Amgen and pharmacy benefit manager Abarca announce outcome based agreement for Enbrel®, under which Amgen will provide rebates to Abarca’s clients who start etanercept to treat RA but discontinue treatment after 3 months.  This is the second outcome-based between Abarca and Amgen, the prebvious (2018) arrangement related to hyperlipidemia medicine Repatha.

US | Mylan and Biocon launch Ogivri® in US

December 2, 2019

Mylan and Biocon announce the launch of Ogivri® in the US.

US | Patent dispute between Amneal and Amgen settles

November 28, 2019

Amneal and Amgen settle patent dispute over filgrastim biosimilar. Notice of the settlement was approved by a US Federal Court, however no further details have been published. Amgen had filed the complaint against Amneal in March 2018, alleging infringement of a number of patents.

EU | Coherus and Amgen announce AmAb settlement

November 27, 2019

Coherus and Amgen settle suit over adalimumab. Notice of the agreement has been approved by a US Federal Court, however no further details about the settlement have been published. This dispute arose when Amgen launched Amgevita® in Europe in 2018 (manufactured in the US), with Coherus alleging the product infringed 4 of its own patents. 

US | FDA approves Biocon’s sBLA

November 27, 2019

Biocon announces its supplemental BLA (sBLA) for biosimilar pegfilgrastim has been approved by the FDA. This additional approval relates to FDA approval of Biocon’s new manufacturing facility in Bengalaru.

Shanghai Henlius Phase III clinical trial results released

November 26, 2019

Shanghai Henlius announces proposed trastuzumab biosimilar met primary endpoint in Phase III clinical trials.

US | Coherus and Bioeq obtain licensing agreement for Lucentis®

November 23, 2019

Coherus and Bioeq announce licensing agreement for Lucentis® (ranibizumab) in the US. Under the agreement, Bioeq will receive upfront and launch milestone payments, with both parties sharing the profits.

AU | Pfizer receives Australian approval for bevacizumab biosimilar, Zirabev®

November 21, 2019

Pfizer receives Australian approval for bevacizumab biosimilar, Zirabev®.

US | FDA accepts BLA for proposed bevacizumab biosimilar

November 19, 2019

FDA accepts BLA for proposed bevacizumab biosimilar.

Phase III trials of natalizumab biosimilar commence

November 18, 2019

Polpharma commences dosing in Phase III trials of proposed natalizumab biosimilar.

US | Sandoz launches discounted Ziextenzo®

November 16, 2019

Sandoz launches pegfilgrastim product, Ziextenzo®, in the US, at a 37% discount to the reference product, Neulasta®.

US | FDA approves Abrilada®

November 15, 2019

FDA approves Pfizer’s adalimumab biosimilar Abrilada®. This product will not be launched until November 2023, under the terms of Pfizer’s agreement with AbbVie entered into in November 2018.

Sandoz releases results of Erelzi® studies

November 12, 2019

Sandoz releases results of Erelzi® studies, including interim results of the COMPACT study, and long-term cost savings modelling analysis.

CN | China’s NMPA approves Qletli®

November 7, 2019

Bio-Thera announces China’s National Medicinal Products Administration has approved its biosimilar adalimumab, Qletli® for the treatment of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

Teva and Celltrion’s discounted Truxima® is launched

November 7, 2019

Teva and Celltrion announce launch of Truxima® in the US, at a 10% price reduction compared to Rituxan®.

CN | Biogen acquires rights to Samsung’s Imraldi®

November 6, 2019

Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilar ranibizumab and aflibercept for major markets world side including the US, Canada, Europe, Japan and Australia. Biogen has also acquired exclusive commercialisation rights for its anti-TNF portfolio, including BENEPALI® (etanercept), FLIXABI® (infliximab) and IMRALDI® (adalimumab), in China.  Under the agreement, Biogen will make one $100 million upfront payment, with up to $210 million payable at additional development, regulatory and sales-based milestones.

Henlius Biotech’s biosimilar rituximab recognised

November 6, 2019

Henlius Biotech wins ‘Biosimilar Initiative of the Year’ for its biosimilar rituximab at the Global Generics and Biosimilars Awards.

US | Avsola® approved by FDA

November 6, 2019

FDA approves Avsola® for all indications.

CN | Biogen and Samsung Bioepis partnership for commercialisation announced

November 6, 2019

Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilar ranibizumab and aflibercept for major markets world side including the US, Canada, Europe, Japan and Australia. Biogen has also acquired exclusive commercialisation rights for its anti-TNF portfolio, including BENEPALI® (etanercept), FLIXABI® (infliximab) and IMRALDI® (adalimumab), in China.  Under the agreement, Biogen will make one $100 million upfront payment, with up to $210 million payable at additional development, regulatory and sales-based milestones.

Biogen and Samsung Bioepis announce partnership for the commercialisation of ranibizumab and aflibercept

November 6, 2019

Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilars ranibizumab and aflibercept. The agreement covers the US, Canada, Europe, Japan and Australia. Under the agreement, Biogen will make one $100M upfront payment, with up to $210M payable at additional development, regulatory and sales-based milestones.

US | Sandoz’s Ziextenzo® approved

November 5, 2019

FDA approves Sandoz’s pegfilgrastim biosimilar Ziextenzo®.

Gene Techno Science and Kishi Kasei announce agreement for joint development of an aflibercept biosimilar

November 3, 2019

Gene Techno Science and Kishi Kasei announce agreement for the joint development of an aflibercept biosimilar.

Data from Inflectra® analysis released

November 2, 2019

Pfizer releases positive interim analysis of data from clinical trials of Pfizer’s Inflectra®.

AbbVie reports decrease in Humira® revenues due to biosimilar competition

November 1, 2019

AbbVie releases Third-Quarter results, showing an overall decrease in Humira® revenues of 3.7% due to biosimilar competition. While Humira® revenues continued to increase in the US by 9.6%, internationally revenues decreased by 33.5%.

Formycon announced dosing has begun in Ph I trials of biosimilar ustekinumab

October 28, 2019

Formycon announces dosing has begun in PhI clinical trials of ustekinumab biosimilar.

EU | CHMP recommends marketing authorisation for Mundipharm’s pegfilgrastim

October 25, 2019

The CHMP adopts a positive opinion for Mundipharma’s pegfilgrastim candidate, recommending marketing authorisation be granted.

Celltrion 3 post marketing studies of etanercept biosimilar results released

October 24, 2019

Celltrion presents pooled data from 3 post marketing studies of etanercept biosimilar, reporting that the study shows real-world evidence of the safety of the product.

Results of Phase I clinical trials of infliximab biosimilar released

October 19, 2019

Amgen releases results of Phase I clinical trials of infliximab biosimilar, reporting PK similarity as well as similar safety and immunogenicity profiles.

NeuClone announces commenced dosing in Ph I trials of biosimilar ustekinumab

October 17, 2019

NeuClone announces it has commenced dosing in Phase I clinical trials of biosimilar ustekinumab candidate. 

Archigen Biotech fails to develop Rituxan biosimilar

October 16, 2019

Samsung executives admit subsidiary Archigen Biotech failed to develop a Rituxan biosimilar. The admission was made in Korean court court proceedings, with 8 executives and employees of Samsung facing accounting fraud charges.

Results from Phase III clinical trials of MabThera/Rituxan® released

October 14, 2019

Roche announces results of Phase III clinical trials of MabThera/Rituxan® compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). Roche has announced that the results demonstrate Rituxan’s superiority over MMF for PV patients.

Details of clinical trials of biosimilar natalizumab candidate published

October 13, 2019

Polpharma publishes details of upcoming phase III clinical trials of biosimilar natalizumab candidate. The study will involve approximately 260 patients with relapsing-remitting multiple sclerosis.

Prestige release details of upcoming Ph III clinical trials of biosimilar bevacizumab

October 12, 2019

Prestige releases details of upcoming Phase III clinical trials of biosimilar bevacizumab candidate.

Alteogen announces Ph I clinical trials of aflibercept

October 12, 2019

Alteogen announces Phase I clinical trials of biosimilar aflibercept candidate will begin this month.

US | Lupin plans to file US market applications for biosimilar etanercept

October 11, 2019

Lupin announces plans to file applications for biosimilar etanercept in the US market by the fourth quarter of FY20.

Results of Samsung Bioepis Benepali® psoriasis study released

October 9, 2019

Samsung Bioepis releases results of Benepali® psoriasis study, announcing results demonstrate the product’s effectiveness and safety in a real-world setting. The study was conducted by the British Association of Dermatologists, Biologics and Immunomodulators Registry and enrolled 269 patients with moderate to severe psoriasis.

US | Humira® identified in Report on Unsupported Price Increases

October 8, 2019

The Institute for Clinical and Economic Review releases its report on Unsupported Price Increases, highlighting AbbVie’s Humira® as one of the products with price increases which are unsupported by new clinical evidence. 

Report on Unsupported Price Increases regarding Roche’s Rituxan® released

October 8, 2019

The Institute for Clinical and Economic Review releases its report on Unsupported Price Increases, highlighting Roche’s Rituxan® as one of the products with price increases which are unsupported by new clinical evidence. 

Celltrion and Juno enter co-marketing partnership agreement for Herzuma® and Truxima®

October 3, 2019

Celltrion and Juno announce Australian co-marketing partnership agreement for Herzuma® (trastuzumab) and Truxima® (rituximab). Under the agreement, Celltrion will hold the marketing authorisation and will be responsible for distribution, and Juno will provide sales promotion and hospital contracting services.

US | FDA responds to Tanvex’s proposed filgrastim biosimilar

September 25, 2019

FDA issues a complete response letter for Tanvex’s proposed filgrastim biosimilar. Tanvex has announced that the FDA did not request additional clinical data or express concern related to product safety, but that certain items needed to be addressed before the application could be approved.

EU | CMHP approves of additional indication for Remsima®

September 22, 2019

CMHP adopts positive opinion for additional indication for Remsima®, to include the treatment of rheumatoid arthritis.

Innovent releases results of Ph III clinical trials of bevacizumab biosimilar

September 19, 2019

Innovent releases results of Phase III clinical trials of bevacizumab biosimilar, reporting no statistical difference in media progression-free survival rates.

Dr Reddy’s Ph III trials of biosimilar rituximab commence

September 19, 2019

Dr Reddy’s commences enrolment for Phase III trials of biosimilar rituximab

iBio enters initial “Statement of Work”

September 18, 2019

iBio announces it has entered into an initial “Statement of Work” under its MOU with AzarGen Biotechnologies. iBio will manufacture research quantities of a plant-made rituximab using iBio’s proprietary FastPharming™ System.

CA | Celltrion biosimilar trastuzumab approved for treatment

September 11, 2019

Celltrion announces Canadian approval for its biosimilar trastuzumab, Herzuma®, for the treatment of HER-2 positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

BR | Samsung Bioepis receives Brazilian approval for Brenzys®

September 10, 2019

Samsung Bioepis announces Brazilian approval for Brenzys®. For the first 10 years, Samsung Bioepis willl supply the drug to local distributors, during which a technology transfer with local partners will take place, allowing local partners to take over manufacturing after this period.

EU | Janssen announces EC approval for additional indication for Stelara®

September 9, 2019

Janssen announces EC approval for additional indication for Stelara®. Stelara® is now indicated for the treatment of ulcerative colitis.

 

JHL ceases development and clinical trials for settlement deal with Genentech

September 9, 2019

JHL announces it will immediately cease development and clinical trials of a number of biosimilars including rituximab, trastuzumab and bevacizumab as part of a settlement deal with Genentech. This agreement settles the 2018 dispute between the two parties, in which it was alleged that JHL had illegally obtained trade secrets from Genentech relating to these products.

EU | Alexion reveals EPO denied two eculizumab patent applications

September 9, 2019

Alexion reveals that the EPO denied two patent applications relating to its eculizumab product, as they await the full written response.

AU | Ziextenzo® approved by Australia’s TGA

September 6, 2019

Australia’s TGA approves Ziextenzo® in 6mg/0.6mL solution for injection prefilled syringe for the treatment of cancer patients following chemotherapy.

TOT Biopharm releases results of Ph I study

September 5, 2019

TOT Biopharm releases results of Phase I study of proposed BmAb biosimilar, reporting PK similarity and safety in comparison to the originator.

Pfizer and Polpharma licensing deal for natalizumab biosimilar

September 3, 2019

Pfizer and Polpharma announce licensing deal for natalizumab biosimilar.  Under the agreement, Polpharma will develop, manufacture and supply the product, while Sandoz will be responsible for commercialisation and distribution.

 

Celltrion’s partnership with Lonza announced

September 3, 2019

Celltrion announces patnership with Lonza for the production of Remsima®. Lonza will now work within Celltrion’s network to complement Celltrion’s own production capacity.

US | US PTAB commences inter partes review of eculizumab patents

September 2, 2019

US Patent and Trial Board commences an inter partes review of Alexion’s eculizumab patents following Amgen’s claims that they were anticipated or obvious.

UK | NHS reports £110 million in AmAb savings

August 31, 2019

NHS announces saving of £110 million by using AmAb biosimilars since AbbVie’s Humira® lost patent protection in October 2018.

Innovent announces reults of Ph III AmAb trials

August 30, 2019

Results of Phase III trial of proposed adalimumab biosimilar demonstrate therapeutic equivalence in terms of efficacy, safety and immunogenicity. The results, published in the first issue of the Lancet Rheumatology, support Innovent’s bid to launch the first biosimilar adalimumab in China.

Henlius commences recruitment for Ph I clinical trials

August 30, 2019

Henlius commences recruitment for Phase I clinical trial of bevacizumab candidate. The trial will enrol 30 patients with solid tumours and is expected to commence in September 2019.

US | FDA approves Taltz® (ixekizumab) for the treatment of ankylosing spondylitis

August 26, 2019

Eli Lilly announced that the FDA has approved Taltz® (ixekizumab) for the treatment of adults with active ankylosing spondylitis.

Results of comparative clinical study into Amgen rituximab biosimilar candicate released

August 22, 2019

Amgen presents results of clinical study comparing safety and efficacy of rituximab biosimilar candidate to originator, reporting clinical equivalence.

JA | Celltrion Herzuma® approved in Japan

August 22, 2019

Celltrion announces Japanese approval for three-week cycle of Herzuma® for the treatment of breast cancer.

US | Amgen and Mylan enter US District Court’s joint status report

August 21, 2019

Amgen and Mylan enter joint status report in US District Court agreeing Mylan did not infringe Amgen’s ‘707 patent. This comes after the Federal Court affirmed Sandoz did not infringe Amgen’s ‘837 patent either.

IN | Dr Reddy’s launces bevacizumab biosimilar Versavo® in India

August 19, 2019

Dr Reddy’s launches bevacizumab biosimiliar Versavo® in India. The product is available in 100mg and 400mg single use vials and is indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer.

JHL Biotech publishes ustekinumab biosimilar is under development

August 16, 2019

JHL Biotech publishes ustekinumab biosimilar is under development.

Samsung Bioepis commences Ph III eculizumab trials

August 16, 2019

Samsung Bioepis commences patient enrolment for Phase III clinical study of eculizumab biosimilar candidate, SB12.

AU | Celltrion anticipates launch of biosimilar products

August 14, 2019

Celltrion remains optimistic ahead of Truxima® launch, despite difficulty with biosimilar uptake in Australian market. Expanding its Australian office from 4 to 15 people, the company is hoping to launch 3 biosimilar products in Australia in the next 3 years, including Truxima® and Herzuma®.

Bio-Thera trials proposed golimumab biosimilar

August 14, 2019

Bio-Thera announces commencement of Ph I trials of proposed golimumab biosimilar.

US | Regeneron announces FDA approval for Eylea® in 2mg prefilled syringe

August 13, 2019

Regeneron announces FDA approval for Eylea® in 2mg, single dose prefilled syringe. The product is expected to launch this year and will require fewer preparation steps in comparison to the previously approved vials.

AU | Quarterly etanercept data reveals slow uptakes of biosimilar in AU market

August 12, 2019

Quarterly etanercept data reveals biosimilar uptake remains slow in the Australian market. While the uptake of Brenzys® (MSD) has steadily grown, the biosimilar still only forms 15% of total scripts.

US | US District Court rules against Sandoz in patent litigation

August 9, 2019

Sandoz announces US District Court ruled against Sandoz in patent litigation, preventing the launch of Erelzi®. Sandoz has announced that they will appeal this decision, and that both parties have agreed to an expedited appeal.

Momenta drops proposed AmAb biosimilar

August 2, 2019

Momenta announces it has dropped proposed AmAb biosimilar candidate, M923, citing changes in market opportunity due to patent litigation settlements.

AU | Mylan and Biocon Ogivri® launches in Australia

August 1, 2019

Mylan and Biocon announce the launch of Ogivri® in Australia. This is the first TmAb biosimilar to be listed on the PBS, following approval in December 2018.

Results of study on Lucentis® with Razumab®

August 1, 2019

New study compares short-term effects of Lucentis® with biosimilar, Razumab® on vision and central foveal thickness (CFT). The study reveals that after one month,  CFT improved in 85.7% of the ranibizumab biosimilar group, and in 86.8% of the ranibizumab group.

Patient enrolment for Phase III clinical trials announced by Celltrion

July 31, 2019

Celltrion announces commencement of patient enrolment for Phase III clinical trials of subcutaneous biosimilar infliximab,CT-P13.

US | Coherus announces non-infringement of Udencya®

July 29, 2019

Coherus reports “victory” in patent dispute with Amgen, announcing that the US Federal Circuit affirmed the District Court’s (Delaware) finding that Coherus’ biosimilar Udencya® does not infringe Amgen’s 8,273,707 patent.  Amgen commenced this BPCIA suit on 10 May 2017, the District Court granted Coherus’ motion to dismiss in March 2018, the appeal was heard on 8 May 2019, and the Fed Cir decision handed down on 29 July 2019.

Alvotech and Cipla announce AmAb deal

July 29, 2019

Alvotech and Cipla announce they have entered an exclusive arrangement relating to the commercialisation of AVT02, Alvotech’s biosimilar adalumimab.  Alvotech is responsible for development and supply of the product, while Cipla is responsible for registration and commercialisation. AVT02 is in Phase-3 clinical development with an expectation that applications will be filed with EMA and FDA by “early 2020”.

EU | CHMP suggests additional indication of Lucentis®

July 25, 2019

Novartis announces positive CHMP opinion for additional indication of Lucentis®: the treatment of retinopathy of prematurity in preterm infants.

JCR announces results of Ph III darbepoetin trials

July 25, 2019

JCR announces results of Ph III trials of biosimilar darbepoetin candidate JR131 in patients with renal anemia. 159 patients enrolled in the 52 week study, with JCR reporting no adverse drug reactions, and that patient hemoglobin levels remained within the required 10.0 to 12.0 g/dL range throughout the study.

US | FDA approves Hadlima®

July 24, 2019

Samsung announces FDA approval of adalimumab biosimilar, Hadlima® for RA, JIA, PSA, Crohn’s, UC, PP and AS.  This is Samsung’s third biosimilar anti-TNF Ab approval in the US.  It will be marketed by Merck in the US, after 30 June 2023 pursuant to the terms of Samsung’s settlement with AbbVie.

US | FDA approves Ruxience® for treatment

July 23, 2019

Pfizer announces FDA approval for rituximab biosimilar rituximab (Ruxience®) for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis. This is the second biosimilar RmAb approved in the US, following the approval of Celltrion’s Truxima in November 2018.

Sandoz commences patient enrolment in Ph I/III denosumab trials

July 23, 2019

Sandoz announces commencement of patient enrolment in Ph I/III trials of proposed biosimilar denosumab. A total of 520 osteoporosis patients will be enrolled in the 52 week study.

US | Amgen’s suit against Tanvex

July 23, 2019

Amgen files new patent infringement suit against Tanvex. Amgen’s complaint alleges that Tanvex did not provide certain manufacturing information required by BPCIA legislation.

EU | Samsung announces application for BmAb has been accepted for review by EMA

July 19, 2019

Samsung announces that its application for BmAb candidate SB8 has been accepted for review by the EMA.

AU | Amgen and Celltrion biosimilar trastuzumab products considered for PBS listing

July 19, 2019

Both Amgen and Celltrion’s biosimilar trastuzumab products, Kanjiti® and Herzuma® respectively, were considered by Australia’s PBAC committee for PBS listing and A flagging (substitution).  This follows the May 2019 PBAC recommendations for PBS listing of Mylan and MSD’s biosimilar products.

US | Amgen launches Mvasi® in the US

July 18, 2019

Amgen launches Mvasi® in the US. Mvasi is approved for five types of cancer and was the first oncology therapeutic biosimilar approved by the FDA.

CN | Celltrion announces creation of JVCo for commercialisation

July 18, 2019

Celltrion announces creation of JVCo with Nan Fung Group for the commercialisation of Remsima®, Truxima® and Herzuma® in China. The joint venture company, Vcell Healthcare will obtain exclusive rights to develop, manufacture and commercialise these three products in mainland China.

US | Genentech request for injunction against Amgen rejected

July 18, 2019

US District Court refuses Genentech’s request for a temporary restraining order and preliminary injunction against Amgen following Amgen’s launch of biosimilar trastuzumab Kanjinti®. In a memorandum opinion the Court has called Genentech’s request ‘contrary to the spirit’ of the BPCIA, stating that Genentech had been given warning of the upcoming launch in May 2018.

CN | Celltrion JV Co created for commercialisation of Remsima®, Truxima® and Herzuma®

July 18, 2019

Celltrion announces creation of a JV Co with Nan Fung Group for the commercialisation of Remsima®, Truxima® and Herzuma® in China. The new company Vcell Healthcare will obtain exclusive rights to develop, manufacture and commercialise these three products in mainland China.

CN | Creation of JV Co with Nan Fund Group for commercialisation announced by Celltrion

July 18, 2019

Celltrion announces creation of JV Co with Nan Fung Group for the commercialisation of Remsima®, Truxima® and Herzuma® in China. The joint venture company, Vcell Healthcare will obtain exclusive rights to develop, manufacture and commercialise these three products in mainland China.

Alvotech completes enrolment of Ph III AmAb trials

July 15, 2019

Alvotech announces completion of enrolment in Phase III trials of biosimilar adalimumab AVT02.  407 participants across Europe have enrolled, while Phase I PK trials are ongoing.

Celltrion announces the launch of Clinical trials of omalizumab biosimilar

July 15, 2019

Celltrion announces start of Phase I Clinical trials of omalizumab biosimilar, with Phase III trials expected to begin in the first half of 2020.

Study results for mAbxienxe’s biosimilar rituximab

July 11, 2019

Study finds mAbxienxe’s biosimilar rituximab candidate RTXM83 is not inferior to the reference drug in terms of efficacy.

ES | EU | Mylan launches Hulio® in Spain

July 9, 2019

Mylan launches Hulio® in Spain following EC approval in September 2018.

Catalyst Biosciences announces results of Ph II eptacog alfa trials

July 8, 2019

Catalyst Biosciences announce eptacog alfa biosimilar met primary endpoints in Ph II trials.

Study results into efficacy of rituximab released

July 7, 2019

A new study reveals rituximab may be effective in managing mixed cryoglobulinemic vasculitis.

US | Samsung and Genentech Ontruzant® patent dispute settles

July 4, 2019

Samsung and Genentech settle patent dispute, allowing for the sale of Samsung’s Ontruzant®.

Prestige enters agreements with Pharmapark and Munipharma for Tuznue®

July 2, 2019

Prestige announces agreements with Pharmapark and Mundipharma for the supply and commercialisation of Tuznue® . An agreement reached with Pharmapark allows for supply and commercialisation in Russia, while the agreement with Mundipharma grants an exclusive license and supply of the drug.

EU | Amgen’s Marketing Authorisation application withdrawn

July 1, 2019

Amgen withdraws its Marketing Authorisation application for biosimilar infliximab ABP710, citing a change in product strategy.

Shanghai Biomabs commences Ph I denosumab trials

July 1, 2019

Shanghai Biomabs commences Ph I trials of biosimilar denosumab candidate.

Filgrastim in stem cell mobilisation

July 1, 2019

Study reveals outcomes for the use of filgrastim in stem cell mobilisation prior to transplant, recording similar outcomes for tbo-filgrastim, the reference drug and biosimilar filgrastim (Zarxio).

US | FDA approves Pfizer’s bevacizumab biosimilar, Zirabev®

June 28, 2019

FDA approves Pfizer’s bevacizumab biosimilar, Zirabev® for the treatment of metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent gliobastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.

EU | EMA accepts Henlius’ MAA for trastuzumab biosimilar HLX02

June 21, 2019

Henlius announces that EMA has accepted Henlius’ MAA for trastuzumab biosimilar HLX02. This is the first Chinese developed TmAb biosimilar to be accepted for review by the EMA.

Sandoz announces results of Hyrimoz® switching studies

June 14, 2019

Sandoz announces results of Hyrimoz® switching studies in patients with moderate-to-severe rheumatoid arthritis, announcing no clinically meaningful differences in safety, efficacy or immunogenicity.

US | Amgen biosimilar TmAb Kanjinti® approved

June 13, 2019

FDA approves Amgen’s biosimilar TmAb Kanjinti® for all indications.

US | Roche’s BLA accepted and Rituxan® under review

June 12, 2019

FDA accepts Roche’s BLA and grants priority review to Rituxan® for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children. The FDA is yet to approve any treatments for these blood vessel disorders.

EU | Imraldi dominates 46% share of EU AmAb biosimilar market

June 4, 2019

Samsung BioLogics announces Imraldi® dominates 46% share in European adalimumab biosimilar market.

EU | Samsung Bioepis announces Benepali® share in EU etanercept biosimilar market

June 4, 2019

Samsung Bioepis announces Benepali® dominates 40% share in European etanercept biosimilar market.

Innovent presents results of efficacy and safety study

June 3, 2019

Innovent presents results of efficacy and safety study of BmAb biosimilar at the Annual Meeting of the American Society of Clinical Oncology (ASCO).

Xbrane and STADA expand biosimilar development partnership

May 31, 2019

Xbrane and STADA announce expansion of biosimilar development partnership. This expansion will now include the development of Xbrane’s biosimilar candidates certolizumab pegol and nivolumab, as well as other biosimilars.

JA | Genentech’s infringement suit against Sandoz dismissed

May 29, 2019

Tokyo District Court judge dismisses Genentech’s infringement suit against Sandoz and its local marketing partner Kyowa Hakko Kirin.

Results of 24 week switching study on Sandoz candidate released

May 29, 2019

Results of 24 week switching study released, citing no changes in safety or efficacy outcomes. The study was conducted in patients with moderate to severe rheumatoid arthritis and compared the outcomes of those who swapped to the Sandoz candidate at 24 weeks and those who continued with the reference drug.

EU | Prestige Biopharma’s application for Tuznue® accepted

May 28, 2019

The EMA accepts Prestige Biopharma’s application for trastuzumab biosimilar Tuznue®.

CA | Ogivri® approved by Health Canada for treatment of breast cancer and metastatic stomach cancer

May 22, 2019

Health Canada approves Ogivri® for the treatment of HER2-positive breast cancer and HER2-positive metastatic stomach cancer. The product is the first TmAb biosimilar to be approved in Canada and is expected to be launched in the current quarter.

US | Genentech moves to dismiss Pfizer’s counter-claims

May 20, 2019

Genentech moves to dismiss Pfizer’s counter-claims, claiming that BPCIA legislation prevents any declaratory judgement as Pfizer did not comply with requirements during the ‘patent dance’.

AU | Amgen biosimilar trastuzumab Kanjinti® approved

May 16, 2019

Amgen receives Australian approval for biosimilar trastuzumab Kanjinti®, in 60mg, 150mg and 420mg dosages.

AbbVie and Boehringer Ingelheim announce AmAb settlement

May 15, 2019

AbbVie announces global settlement with Boehringer Ingelheim. This is the 9th global deal AbbVie has entered into, with BI securing a US market entry date of 1 July 2023, after Amgen (31 Jan 2023) and Samsung Bioepis (30 Jun 2023), and before Mylan (31 Jul 2023), Fresenius Kabi and Sandoz (30 Sept 2023), Momenta Pharmaceuticals and Pfizer (20 Nov 2023), and Coherus BioSciences (15 Dec 2023). The agreement is royalty bearing, however no further details have been released.

NeuClone confirms Ph I trials of biosimilar ustekinumab

May 15, 2019

NeuClone confirms Ph1 trials of biosimilar ustekinumab will commence in the second half of 2019, as previously announced.

US | Sandoz affirmed by Federal Court

May 10, 2019

Federal Court affirms District Court finding Sandoz did not infringe Amgen’s ‘837 patent.

US | Federal court affirms District Court regarding Sandoz v Amgen

May 10, 2019

Federal Court affirms District Court finding Sandoz does not infringe Amgen’s ‘837 patent.

Results of Phase III clinical trials of rituximab biosimilar released

May 9, 2019

Innovent and Eli Lilly announce rituximab biosimilar IBI301 met primary endpoints in Phase III clinical trials and PK study.

US | Pfizer responds to Genentech’s complaint

April 29, 2019

Pfizer responds to Genentech’s complaint, seeking declaratory judgement of invalidity and noninfringement of all of the patents in Genentech’s complaint.

US | Amgen and Roche file suit alleging infringement of patents in response to FDA approval of Eticovo®

April 29, 2019

In response to FDA approval of Eticovo®, Amgen and Roche file a suit alleging the infringement of five patents. Within the complaint, Amgen and Roche allege that Samsung failed to provide them with a copy of its aBLA or details of the manufacturing process, as well as failing to provide the 180 day notice of commercial marketing.

US | FDA approves biosimilar etanercept Eticovo®

April 29, 2019

FDA approves biosimilar etanercept Eticovo® for all eligible indications (RA, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis).

Xbrane Phase III trials for Xlucane® commence

April 23, 2019

Xbrane commences Phase III trials for biosimilar ranibizumab candidate Xlucane®.

Sandoz reports results of long term studies on infliximab biosimilar

April 19, 2019

Sandoz reports results of long term studies (up to 54 weeks) on the efficacy, safety and immunogenicity of infliximab biosimilar.  This product was initially developed by Pfizer and acquired by Sandoz.

AU | Sandoz and Roche settle dispute over rituximab biosimilar

April 11, 2019

Sandoz and Roche settle long-running AU Federal Court dispute over rituximab biosimilar, allowing for the launch of Sandoz product Riximyo® “in the near future”.  The 2017 Federal Court proceedings before Burnley J were dismissed.

RU | Selexis announces first biosimilar eculizumab approval in Russia

April 11, 2019

Selexis announces first biosimilar eculizumab approval in Russia through partnership with Generium. 

CA | Teva’s Truxima® approved by Health Canada

April 10, 2019

Health Canada approves Teva’s Truxima® for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis in adult patients.

JA | Alvotech and Fuji Pharma announce exclusive agreement for commercialisation of Stelara®biosimilar in Japan

April 9, 2019

Alvotech and Fuji Pharma announce exclusive agreement for the commercialisation of Stelara® biosimilar in Japan. Alvotech will be responsible for development and supply while Fuji Pharma will receive exclusive rights to commercialise the drug in Japan. This follows Fuji Pharma’s recent US $50 million investment in Alvotech.

 

 

US | Genentech files complaint against Pfizer

April 5, 2019

Genentech files complaint against Pfizer in the District Court of Delaware alleging infringement of 22 patents and requesting a declaratory judgment of infringement of several of these patents.

EU | EMA approves Idacio®

April 3, 2019

Fresenius Kabi announces European Commission approval of biosimilar adalimumab, Idacio® for all indications. 

US | Sandoz resubmits BLA for pegfilgrastim biosimilar candidate

April 2, 2019

Sandoz announces resubmission of its BLA for pegfilgrastim biosimilar candidate, including new data from pharmacokinetics and pharmacodynamics studies.

US | Baltimore files class action against AbbVie

April 2, 2019

The Mayor and City Council of Baltimore files additional class action against AbbVie, alleging that anti-competitive behaviour prevented the introduction of biosimilars and allowed AbbVie to demand ‘supra competitive prices’. Additionally, the complaint alleges that through the agreements reached with AbbVie, Amgen has been awarded a 5 month period with reduced competition as the only biosimilar available from January 2023.

Celltrion completes recruitment of Ph III AmAb trials

March 28, 2019

Celltrion announces completion of recruitment for Phase III clinical trials of biosimilar adalimumab.

JP | Lupin biosimilar etanercept approved in Japan

March 26, 2019

Lupin announces approval of biosimilar etanercept in Japan for the treatment of moderate to severe Rheumatoid Arthritis. 

US | UFCW Local 1500 Welfare Fund files class action against AbbVie, Amgen, Samsung, Mylan, Sandoz, Fresenius, Pfizer and Momenta

March 18, 2019

UFCW Local 1500 Welfare Fund, a grocery union, files class action against AbbVie, Amgen, Samsung Bioepis, Mylan, Sandoz, Fresenius Kabi, Pfizer and Momenta, alleging misconduct and antitrust violations. The union alleges that the hundreds of patents which protect Humira® and settlements reached which the other seven companies have resulted in a monopoly which has prevented any competition. The class action includes persons or entities who have purchased or paid for Humira® since January 1, 2017.

AU | Celltrion biosimilar products recommended for PBS listing

March 16, 2019

PBAC Committee recommends all 4 brands of Celltrion biosimilar products (Tuxella®, Rituzena®, Ritemvia®, Truxima) for PBS listing in AU for all TGA registered indications for which the reference brand Mabthera is currently listed on the PBS, despite approved skinny label). 

EU | EC approves label expansion of MabThera®

March 15, 2019

Roche announces EC approval for a label expansion of MabThera®. The approval now includes the treatment of pemphigus vulgaris, the first major advancement for the treatment of this disease in more than 60 years.

UK | Investigation into Merck discount scheme closes

March 14, 2019

UK Competition and Markets Authority closes investigation into Merck discount scheme after finding no grounds for further action. This decision is contrary to the provisional findings in May 2017 which indicated a breach of competition law.

Alvotech commences Ph III AmAb trials

March 13, 2019

Alvotech commences Phase III trial of 100mg/mL adalimumab biosimilar. 400 participants will be enrolled across 30 sites in Europe in this comparability study.

US | FDA approves Pfizer biosimilar trastuzumab Trazimera® for treatment

March 11, 2019

Pfizer announces FDA approval of biosimilar trastuzumab Trazimera® for the treatment of HER2 positive breast cancer and HER2 metastic gastric or gastroesophageal junction adenocarcinoma.

Celltrion’s formulation of infliximab biosimilar demonstrates safety

March 8, 2019

Celltrion claims results of 1 year comparison study of subcutaneous formulation of infliximab biosimilar demonstrate comparable efficacy and safety with intravenous formulation.

UK | Napp launches Pelmeg®

March 1, 2019

Napp launches biosimilar pegfilgrastim, Pelmeg®, in the UK. This biosimilar was developed by Cinfa Biotech and acquired by Mundipharma.

AU | TGA approves Hyrimoz®

March 1, 2019

Sandoz obtains Sandoz Australian approval for biosimilar adalimumab Hyrimoz®. This is the third biosimilar adalimumab approval in Australia.

AU | Celltrion Rituzena® and Tuxella® approved

March 1, 2019

Celltrion gains Australian approval for biosimilar rituximab under two product names, Rituzena® and Tuxella®.

CA | Apotex launches Lapelga®

February 28, 2019

Apotex division Apobiologix launches pegfilgrastim biosimilar, Lapelga® in Canada.

US | Subcutaneous formulation of Herceptin approved for treatment of HER2-overexpressing breast cancer

February 28, 2019

FDA approves subcutaneous formulation of Herceptin for the treatment of HER2-overexpressing breast cancer.

US | US court orders Boehringer to disclose AmAb launch plans

February 27, 2019

In ongoing litigation between Boehringer and AbbVie, the court has ordered Boehringer to release its plans for biosimilar adalimumab, Cytelzo®. Cytelzo® has been approved by the FDA but has not yet been launched.

Samsung Bioepis enters commercialisation partnership with C-Bridge

February 26, 2019

Samsung Bioepis partners with C-Bridge to commercialise biosimilars in China. Under the deal, C-Bridge will develop a new company, AffaMed Therapeutics to launch candidates such as ranibizumab, eculizumab and trastuzumab biosimilars.

US | Sandoz files suit against Amgen

February 25, 2019

Sandoz files suit against Amgen, seeking DJ of non-infringement and invalidity. This comes as Sandoz awaits FDA decision on its pegfilgrastim biosimilar, with Sandoz hoping to block any preliminary injunction motions from Amgen.

CN | Hanlikon® is approved

February 25, 2019

China’s National Medical Products Administration approves first rituximab biosimilar, Hanlikon®.

KR | Alteogen announces new drug application for aflibercept

February 22, 2019

Alteogen announces new drug application to the Ministry of Food and Drug Safety for aflibercept biosimilar, ALT-L9.

AU | Phase I trials of biosimilar omalizumab approved

February 21, 2019

Biosana announces approval for Phase 1 trials of biosimilar omalizumab, with results expected in the fourth quarter of 2019.

EU | Pfizer announces EU approval for Zirabev®

February 19, 2019

Pfizer announces EU approval for Zirabev®, biosimilar BmAb.

UK | National Institute for Health and Care Excellence recommends pertuzumab

February 15, 2019

In its final appraisal of pertuzumab, the National Institute for Health and Care Excellence (NICE) has recommended it for the treatment of lympth node-positive disease. The final appraisal comes following the promise of a large discount offered by Roche.

Samsung Bioepis enters partnership with C-Bridge for trastuzumab biosimilars

February 11, 2019

Samsung Bioepis announces partnership with C-Bridge to commercialise biosimilars in China. Under the deal, C-Bridge will develop a new company, AffaMed Therapeutics to launch candidates such as ranibizumab, eculizumab and trastuzumab biosimilars.

EU | Mundipharma launches Pelmeg®

February 5, 2019

Mundipharma launches pegfilgrastim biosimilar, Pelmeg®, in Europe. Pelmeg® was developed by Cinfa Biotech, and is the fourth biosimilar commercialised by Mundipharma.

EU | CHMP recommends granting approval of Fresenius Kabi’s AmAb

February 1, 2019

The CHMP recommends granting approval for two AmAb biosimilars, Idacio® and Kromeya®. Both products are indicated for RA, psoriasis, psoriatic athritis and Crohn’s disease.

AbbVie and Coherus announces AmAb settlement

January 25, 2019

Coherus announces an 8th global deal with AbbVie for the commercialisation of biosimilar AmAb, under which Coherus has global, non-exclusive license rights which are royalty bearing.  Coherus’ US rights commence on 15 Dec 2023, just under a month after Momenta’s & Pfizer’s.

US | Results of Phase I/Phase III study of rituximab biosimilar released

January 24, 2019

Amgen announces results of Phase 1/Phase 3 study of rituximab biosimilar candidate, confirming the study demonstrated favourable efficacy and safety profiles.

Alvotech biosimilar pipeline development announced

January 23, 2019

Alvotech announces development in biosimilar pipeline with $300 million raised through a private bond offering.

Bio-Thera Ph III trials of proposed tocilizumab biosimilar commence

January 22, 2019

Bio-Thera announces commencement of Ph III trials of BAT1806, its proposed tocilizumab biosimilar. Results are expected in the second half of 2020.

US | FD approves Samsung Bioepis biosimilar trastuzumab

January 21, 2019

FDA approves biosimilar trastuzumab for all eligible indications. This is Samsung Bioepis’ first oncology biosimilar to receive FDA approval.

Health Canada approves new indication for Erelzi®

January 21, 2019

Health Canada approves new indication for Erelzi®, allowing for the treatment of psoriatic arthritis. 

Samsung Biogen’s patent for biosimilar rituximab invalidated

January 18, 2019

Celltrion announces success in litigation against Samsung Biogen, invalidating Samsung Biogen’s patent for biosimilar rituximab. 

US | Bio-Thera announces partnership with Cipla

January 14, 2019

Bio-Thera announces partnership with Cipla to commercialise BmAb candidate in emerging markets.

AU | Samsung Bioepis biosimilar trastuzumab Ontruzant® approved

January 9, 2019

Samsung Bioepis obtains AU approval for Ontruzant®, biosimilar trastuzumab, in Australia.  This is the third biosimilar TmAb to be approved in AU, following Celltrion’s approval of Simabtra® in July 2018, and Mylan’s approval of Ogivri® in December 2018.

US | Regeneron announces $4.07 billion in 2018 US net sales for Eylea®

January 7, 2019

Regeneron announces $4.07 billion in 2018 US net sales for Eylea®, as it awaits the commencement of new clinical trials for a high dose formulation.  Additionally, the FDA has assigned 13 May 19 as the action date for a potential new indication in diabetic retinopathy.

CN | Samsung Bioepis enters commercialisation partnership with 3SBio

January 7, 2019

Samsung Bioepis announces partnership with 3SBio to commercialise biosimilars in China. Under the agreement, Samsung Bioepis will be be responsible for manufacturing and supplying the products, while 3SBio will be responsible for regulatory registration and commercialisation.

Celltrion announces direct sales network

January 6, 2019

Celltrion announces it will establish a direct sales network minimising sales partners, including for its biosimilar infliximab, Remsima®.

US | Launch of Udencya® announced by Coherus

January 5, 2019

Coherus announces launch of pegfilgrastim biosimilar Udencya® in the US, confirming sales began on January 3rd.

Alteogen announces it has been granted a process patent for producing aflibercept

January 4, 2019

Alteogen announces it has been granted a process patent for producing aflibercept biosimilar, ALT-L9.  Alteogen reports the process improves the productivity and quality of large-scale production of fusion proteins.

2018

Sandoz enters commercialisation agreement with Gan & Lee Pharmaceutical

December 28, 2018

Sandoz announces agreement with Gan & Lee Pharmaceutical to commercialise biosimilar insulins.

JHL commences randomised Phase III study in China

December 27, 2018

JHL announces first patient in randomised Phase III study conducted in China. The trial is being conducted in patients with previously untreated diffuse large B-cell lymphoma.

Results from Mycenax Ph I PK clinical trials released

December 24, 2018

Mycenax announces positive results from Ph I PK clinical trials, reporting the product met the primary endpoint in PK comparison.

KR | Chong Kun Dang receives approval for biosimilar darbepoetin in South Korea

December 24, 2018

Chong Kun Dang announces approval for biosimilar darbepoetin from the Ministry of Food and Drug Safety of South Korea. This is the first biosimilar darbepoetin to be approved in a highly regulated country.

Shanghai Henlius’ results from TmAb Phase III trials released

December 23, 2018

Shanghai Henlius’ research team presented an update on its TmAb clinical program with Phase III trials underway in Poland, Ukraine, Phillippines and China.

Prestige enters licensing agreement with Cipla

December 23, 2018

Prestige announces licensing agreement with Cipla, granting Cipla exclusive rights to distribute and market Prestige’s TmAb biosimilar in emerging markets.

UK | NHS announces AmAb biosimilars deal

December 20, 2018

The NHS announces negotiations for the supply of adalimumab biosimilars have concluded with Amgen, Biogen, Mylan, Sandoz and AbbVie. This deal is predicted to save the NHS £300M per year.

EU | Biocon biosimilar trastuzumub (Ogivri®) market authorised

December 20, 2018

Biocon announces EU marketing authorisation for biosimilar trastuzumub, Ogivri®. Ogivri® is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastic gastric cancer.

US | TmAb biosimilar FDA approved for treatment of HER2-positive breast cancer

December 20, 2018

FDA approves TmAb biosimilar for the treatment of HER2-positive breast cancer. Herzuma® is the second TmAb biosimilar to be approved in the US. Celltrion is currently defending the biosimilar against Genentech, and while Genentech and Pfizer have reached a settlement, Celltrion, Amgen and Samsung Bioepis remain in litigation.

US | Xbrane submits CRA for clinical trials of Xlucane®

December 19, 2018

Xbrane submits first CTA to FDA for clinical trials of ranibizumab biosimilar candidate, Xlucane®. The Phase III trials will be conducted in patients with wet form of age-related macular degeneration.

US | BLA filed by Amgen

December 17, 2018

Amgen files BLA for biosimilar infliximab.

NeuClone announces preclinical development

December 17, 2018

NeuClone announces that it has biosimilar pertuzumab in preclinical development.

EU | Remsima® approved for treatment

December 15, 2018

French study supports the use of Remsima® in the treatment of Crohn’s disease, showing equivalency to reference product in safety and effectiveness.

AU | Amgen’s Neulasta® and Ristempa® brands declared equivalent for substitution

December 14, 2018

PBAC releases results from November PBAC meeting. The PBAC recommended Alphapharm’s Fulphila® for listing on the PBAC for all indications with “A” flagging.  Fulphila® and Amgen’s Neulasta® and Ristempa® brands of pegfilgrastim are now considered equivalent for the purpose of substitution (i.e. “A” flagged).

EU | EMA Committee for Medical Products for Human Use recommends approval of Pfizer’s

December 14, 2018

The EMA’s Committee for Medicinal Products for Human Use recommends approval of Pfizer’s BmAb biosimilar Zirabev®.  This is Pfizer’s second oncology biosimilar to receive positive EMA opinion this year.

US | Results from study into Celltrion’s Truxima® released

December 14, 2018

Results of two year study demonstrate similar safety and efficacy between Celltrion’s Truxima® and the reference product in the treatment of advanced follicular lymphoma.

Innovent announces BmAb met endpoints in Ph III trials

December 13, 2018

Innovent announces BmAb candidate met pre-defined endpoints in Phase III trials.

Genentech and Pfizer dismisses claims in litigation

December 13, 2018

Genentech and Pfizer voluntarily dismiss all claims in litigation commenced in November 2017, each covering their own legal costs. While no details have been published, the dismissal suggests a settlement has been reached.

AU | Alphapharm Ogivri® receives TGA approval in Australia

December 11, 2018

Alphapharm receives TGA approval for its biosimilar TmAb in Australia (Ogivri®) in 2 dosage forms (150mg, and 440mg powder for injection), four months after Celltrion received approval for its TmAb biosimilar products on 17 July 2018.

US | Results from follow-up study on Samsung Bioepis trastuzumab released

December 8, 2018

Samsung Bioepis announces comparable efficacy and safety to reference Trastuzumab in one-year follow-up study published at the San Antonio Breast Cancer Symposium.

EU | Pfizer withdraws EU AmAb application

December 5, 2018

Pfizer notifies the CHMP it wishes to withdraw its application for Fyzoclad®, biosimilar adalimumab, due to changes in the company’s strategy.  

EU | Celltrion’s application for subcut formulation accepted

December 2, 2018

The EMA accepts Celltrion’s application for a subcut formulation of biosimilar infliximab, Remsima SC®.

EU | Results of Sandoz’s proposed RmAB biosimilar released

December 1, 2018

At the ASH Annual meeting, a paper was presented indicating positive results for Sandoz’s proposed RmAb biosimilar to EU reference drug, and concluding “efficacy, safety and immunogenicity, PK and PD of PF‑05280586 and rituximab-EU were similar up to Week 26 in subjects with previously untreated CD20-positive, LTB-FL”

AbbVie and Pfizer announce AmAb settlement

November 30, 2018

AbbVie announces a 7th global deal for biosimilar adalimumab. A non-exclusive royalty bearing license to Pfizer for AmAb will begin on 20 November 2023 in the US and on approval in the EU (no other dates disclosed).  Pfizer’s US launch date is the same as Momenta’s, 10 months after the first licensed biosimilar launch (Amgen).

US | FDA accepts Tanvex’s BLA

November 28, 2018

Tanvex announces that the FDA has accepted its BLA for biosimilar filgrastim.

US | FDA approves Celltrion’s Truxima® as treatment

November 28, 2018

FDA approves Celltrion’s rituximab biosimilar CTP-10 (Truxima®), for the treatment of non-Hodgkin’s lymphoma. This is the first US biosimilar RmAb to be approved.

JP | First trastuzumab biosimilar launches in Japan

November 28, 2018

Daiichi Sankyo launches first trastuzumab biosimilar in Japan.

EU | Sandoz approves Ziextenzo® for market

November 27, 2018

Sandoz announces EC marketing approval for pegfilgrastim biosimilar Ziextenzo®.

US | EMA approves Pelmeg® for treatment

November 20, 2018

EMA approves biosimilar pegfilgrastim Pelmeg® for patients undergoing cytotoxic chemotherapy for malignancy, with the exceptions of chronic myeloid leukaemia and myelodysplastic syndromes.

AU | Sandoz rituximab biosimilar approved

November 16, 2018

Sandoz receives approval for rituximab biosimilar under two presentations and two brands. The approval includes 500mg/50mL Rixonfya®, 100mg/10 mL Rixonfya®, 500mg/50mL Rixvyda® and 100mg/10mL Rixvyda®. Sandoz is currently prevented from supplying for use, selling, supplying or offering to sell biosimilar rituximab (under injunction) until 11 August 2019, with a Federal Court hearing set down for 3 weeks beginning on 3 June 2019.

CN | China’s NMPA accepts Innovent AmAb application

November 13, 2018

China’s National Medical Products Administration accepts Innovent’s application for biosimilar adalimumab. The application seeks approval for the treatment of ankylosing spondylitis, rheumatoid arthritis, and psoriasis.

US | Coherus discloses discounted biosimilar Udencya®

November 8, 2018

Coherus discloses newly approved biosimilar Udencya® will be available at a 33% discount to Neulasta®, matching the price point for Mylan’s biosimilar Fulphila®. The product is due to be launched on 3 January 2019.

AbbVie and Momenta announce AmAb settlement

November 6, 2018

AbbVie announces a 6th global deal for biosimilar AmAb, this time with Momenta.  Momenta has obtained a global royalty bearing licence beginning on 20 November 2023 for the US, and in the EU “on approval” (no other dates disclosed). Momenta will be able to launch in the US 10 months after Amgen, with Samsung, Mylan, Fresenius and Sandoz able to launch between June and September of 2023.

US | Coherus’ biosimilar pegfilgrastim Udencya® approved

November 2, 2018

FDA approves Coherus’ biosimilar pegfilgrastim Udencya® for patients receiving myelosuppressive chemotherapy. This is the first US/EU approved biosimilar approved for this indication.

US | Sandoz announces withdrawal of biosimilar rituximab

November 2, 2018

Sandoz announces it will not pursue biosimilar rituximab in the US following requests from the FDA for additional information to complement the BLA.

US | Zarxio® recognition

November 1, 2018

Sandoz’s biosimilar Zarxio® is included in Express Script’s 2018 National Preferred Formulary.

US | Sandoz etanercept biosimilar comparable to originator

November 1, 2018

Sandoz reports etanercept biosimilar is comparable to originator at 48 weeks.

US | FDA approves Hyrimoz®

October 31, 2018

FDA approves Sandoz adalimumab biosimilar Hyrimoz® for treatment of rheumatoid arthritis, juvenile idiopathic arthitis, psoriatic arthritis, ankylosing spodylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

Ranibizumab biosimilar Phase III trials announced

October 29, 2018

Samsung announces Phase III trials of ranibizumab biosimilar are underway.

US | Regeneron announces completion of Phase III clinical trials of Eylea®

October 25, 2018

Regeneron announces completion of Phase III clinical trials of Eylea® (aflibercept) in patients with moderately severe and severe non-proliferative diabetic retinopathy.  The company reported the trial met its one year primary endpoint and key secondary endpoints.

NeuClone clinical trials for biosimilar trastuzumab commence

October 23, 2018

NeuClone commences Phase I clinical trials for biosimilar trastuzumab.

EU | Mylan launches Hulio® in EU

October 19, 2018

Mylan announces launch of Hulio®, biosimilar adalimumab in Europe.

US | Genentech announces expanded indication set

October 19, 2018

In advance of US biosimilar competition, Genentech announces expanded indication set, including follow up treatment in adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) who have achieved disease control with induction treatment.

EU | CHMP recommends Mylan and Biocon’s Ogivri® for approval

October 19, 2018

Mylan and Biocon announce the CHMP’s positive opinion recommending Ogivri® (biosimilar TmAb) for approval in EMA.  Approval is expected before the end of the year.

AbbVie and Fresenius reach AmAb settlement

October 18, 2018

AbbVie and Fresenius separately announce global deal with Fresenius Kabi under which Fresenius has a US licence from 30 Sept 2023 (the same date as Sandoz), and may sell in EU on approval.  The deal is global, and different dates apply for other regions.  The Fresenius (and Sandoz) US launch date is 9 months after Amgen’s (31 Jan 2023), 3 months after Samsung Bioepis’ (30 Jun 2023), and 2 months after Mylan’s (31 Jul 2023).

CN | BmAb biosimilar approved by China’s NMPA for clinical development

October 15, 2018

BmAb biosimilar approved by China’s National Medical Products Administration for clinical development for Non-Small Cell Lung Cancer and hepatocellular carcinoma.

EU | Sandoz, Samsung and Amgen launch AmAb products in the EU

October 15, 2018

Sandoz, Samsung and Amgen launch their biosimilar adalimumab products (Hyrimoz®, Imraldi® and Amgevita®) pursuant to the terms of their IP licences with AbbVie.  Mylan also has EMA approval (but no AbbVie EU IP licence) but has indicated an intention to launch their biosimilar Hulio® on or after 16 October.  Similarly Boehringer has no IP licence, but we have no indication of BI’s launch plans for approved Cyltezo®

CN | NMPS approve Ph I and Ph III Clinical Trials for BmAb

October 15, 2018

BmAb biosimilar approved for Phase I and Phase III Clinical Trials by NMPA. 

AbbVie and Sandoz announce global settlement

October 11, 2018

AbbVie announces global settlement with Sandoz, under which Sandoz receives a royalty-bearing, non-exclusive licence to AbbVie’s Humira® patents from 30 Sep 2023 in the US, and 16 Oct 2018 in EU (and other dates elsewhere).  The EU date is the same as AbbVie has given to Amgen and Samsung Bioepis (note – Mylan has no EU license), and the US date is later than those given to Amgen (31 Jan 2023), Samsung Bioepis (30 Jun 2023) and Mylan (31 Jul 2023).

Munidpharma acquires Cinfa Biotech

October 10, 2018

Munidpharma acquires Cinfa Biotech, gaining immediate access to pegfilgrastim biosimilar and a platform to potentially develop more biosimilars in the future.

US | Celltrion CT-P10 recommended for approval

October 10, 2018

US’ Oncologic Drug Advisory Committee unanimously recommends Celltrion’s CT-P10 for approval as a biosimilar to Rituxan.

EU | US | Results of clinical trials for Neulasta® biosimilar released

October 9, 2018

Fresenius Kabi announces that clinical trials for Neulasta® biosimilar met primary endpoints for EU and US.

US | Merck secures development deal to supply rituximab biosimilar

October 7, 2018

Merck secures 5 year, $117.5M deal with US Department of Veterans Affairs to supply rituximab biosimilar developed by Samsung.

Xbrane biosimilar ranibizumab results announced

October 4, 2018

Xbrane announces biosimilar ranibizumab shows equivalent pharmacokinetic profile and equivalent tolerability to originator in study conduct in rabbits.

Momenta announces shift in focus from biosimilars to novel therapeutics

October 1, 2018

Momenta announces a shift in focus from biosimilars to novel therapeutics. The 5 year re-structuring plan will involve cuts to staff of 50%, however the company will continue to develop biosimilar aflibercept candidate M710.

Momenta announces new focus on AmAb biosimilar

October 1, 2018

Momenta announces an end to its strategic review, revealing a sole focus to advance a Humira® biosimilar. Momenta announced it will file a BLA with the FDA and is working to find a commercialisation partner for the product. 

US | FDA accepts Samsung’s AmAb BLA

September 27, 2018

FDA accepts BLA for biosimilar adalimumab. 

EU | EMA approves Hulio®

September 20, 2018

Mylan announces the EU approval of Hulio®, biosimilar adalimumab licensed from Fujifilm in April 2018.

Pre-clinical study results of APZ 001

September 18, 2018

Researchers release results of pre-clinical study of cetuximab candidate APZ001. 

US | FDA announces approval of Amgen’s Mvasi®

September 14, 2018

FDA announces approval of Amgen’s Mvasi®, the first BmAb biosimilar to gain approval in the US

US | Alternative filgrastim products gain favour

September 10, 2018

Significant increase in the use of alternative filgrastim products reported among Medicare Part B beneficiaries.

EU | AryoGen granted GMP certification

September 3, 2018

Iranian AryoGen receives GMP certification from the European Medicines Agency, becoming the first mAb manufacturer in the Middle East and North Africa region to do so. 

CN | China’s CNDA accepts Bio-Thera’s AmAb BLA

August 24, 2018

Bio-Thera announces that the CNDA (China National Drug Administration) has accepted its BLA for biosimilar adalimumab BAT1406.  This is expected to be Bio-Thera’s first drug approval.

US | Pfizer accuses originators of undermining confidence in biosimilars

August 22, 2018

Pfizer accuses originators of using scare campaigns to undermine confidence in biosimilars in a citizen’s petition seeking guidance on the representations which can be made about biosimilar products. Pfizer criticises the slower uptake of biosimilars in the US in comparison to Europe, alleging that false and misleading statements made by originators have contributed to this.

Qilu commences Ph I denosumab trials

August 20, 2018

Qilu commences Ph 1 trials of biosimilar denosumab candidate.

JP | Celltrion’s trastuzumab biosimilar launches in Japan

August 20, 2018

Nippon Kayaku launches Celltrion’s trastuzumab biosimilar in Japan, but only for the treatment of gastric cancers.

UK | Roche’s application for pertuzumab as an adjuvant treatment discouraged

August 20, 2018

The National Institute for Health and Care Excellence (NICE) again recommends against Roche’s application for pertuzumab as an adjuvant treatment in patients with a high risk of recurrence. NICE confirmed its earlier findings that pertuzumab is unlikely to be cost-effective, with clinical trials revealing only a small incremental treatment benefit.

Celltrion set to commence Ph III Clinical Trials for BmAb

August 10, 2018

Celltrion set to commence Phase III Clinical Trials for BmAb biosimilar in 150 sites across Europe, Asia and South America.

US | Amgen’s suit against Apotex

August 7, 2018

Amgen files third suit against Apotex based on aBLAs for biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  The patent under scrutiny, US Patent No. 9,856,287 was issued on 2 January this year and therefore was not included in earlier ‘patent dances’ claiming priority to the original ‘138 patent.  With three additional pending patent applications claiming priority to the ‘138 patent, it is likely that further litigation will result.

US | Third case against Apotex filed for biosimilars of Neupogen® and Neulasta®

August 7, 2018

Amgen files third suit against Apotex based on aBLAs for biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  US patent 9,856,287 was issued on 2 January 2018 and was not included in earlier ‘patent dances’.  With three additional pending patent applications in this family, it is likely that further litigation will result.

Celltrion commences Ph I and III AmAb trials

August 7, 2018

Celltrion announces Phase I and III trials for AmAB biosimilar across 75 sites in 8 European nations, expected to be completed by 2020.

CN | iBio and CC-Pharming enter marketing agreement

August 7, 2018

iBio and CC-Pharming enter agreement to develop biosimilar rituxumab for the Chinese market.

CN | Ph I trials of Clover etanercept biosimilar commence

August 4, 2018

Clover announces that Phase I trials of a potential etanercept biosimilar are underway.

EU | Intas announces release by Accord Healthcare

July 31, 2018

Intas announces subsidiary Accord Healthcare will release pegfilgrastim biosimilar across Europe after receiving a positive response from the Committee for Medicinal Products for Human Use.

EU | EMA approves of Pfizer biosimilar trastuzumab, Trazimera®

July 31, 2018

Pfizer announces EMA approval of biosimilar trastuzumab, Trazimera® for the treatment of human epidermal growth factor (HER2+) breast cancer and HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma.  This is Pfizer’s 4th biosimilar to receive EU approval.

AU | PBAC to list Amgevita and Hadlima as ‘a-flagged’

July 28, 2018

AU’s PBAC has confirmed that Amgen and Samsung’s biosimilar adalimumab (respectively Amgevita and Hadlima) will be “A-flagged”, enabling pharmacy substitution.

EU | CHMP releases a positive response to Coherus

July 27, 2018

Coherus announces that it received a positive response from the CHMP for its pegfilgrastim biosimilar.

EU | EMA approves Sandoz AmAb

July 27, 2018

Sandoz announces EC approval for Hyrimoz®, biosimilar adalimumab for use in all indications.

EU | CHMP adopts positive opinion on Mylan AmAb

July 27, 2018

Mylan and Fujifilm announce positive response from CHMP for biosimilar adalimumab for use in all indications. 

US | Phase I results of biosimilar omalizumab released

July 26, 2018

Glenmark releases Phase I results of biosimilar omalizumab, suggesting similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles to Xolair®.

IN | Dr Reddy’s biosimilar trastuzumab launches in India

July 26, 2018

Dr Reddy’s announces biosimilar trastuzumab available in India for the treatment of HER2-positive cancers.

SA | First biosimilar filgrastim launched in South Africa

July 25, 2018

Teva launches first biosimilar filgrastim in South Africa at 70% of the price of Amgen’s product. This comes more than 5 years after Teva first sought regulatory approval, demonstrating the backlog of products awaiting approval from the South African Health Products Regulatory Authority.

US | FDA approves Nivestym®

July 20, 2018

Pfizer announces FDA approval of Pfizer’s Nivestym®, biosimilar to filgrastim for all indications.

US | AbbVie and Mylan announce global settlement

July 17, 2018

AbbVie announces a global settlement with Mylan under which Mylan acknowledges Humira® AbbVie’s patents are valid, and Mylan receives a royalty-bearing, non-exclusive global license (excluding Europe) from 31 July 2023.  This date will not be accelerated by entry of Amgen or Samsung Bioepis.

AU | Celltrion biosimilar TmAb products approved in Australia

July 17, 2018

Celltrion obtains approval for its biosimilar TmAb products in Australia (150mg products branded as Simabtra®Herzuma®, and Hertuzu®).  These are the first biosimilar TmAb products to be approved in AU.

Xbrane and STADA agreement to develop ranibizumab biosimilar

July 12, 2018

Xbrane and STADA announce they have entered into an agreement to develop a ranibizumab biosimilar for US, EU and other markets.  Under the agreement, Xbrane will be responsible for developing the product while STADA will be responsible for the marketing authorisations and sales and marketing.

EU | Biocon receives EU CGMP certification for Bangalore facility

July 4, 2018

Biocon receives EU CGMP certification for its facility in Bangalore, clearing the way for the approval of pegfilgrastim and trastuzumab biosimilars.

EU | Prestige and Alvogen enter partnership to commercialise Hervelous®

June 28, 2018

Prestige and Alvogen announce partnership to commercialise Prestige’s trastuzumab biosimilar, Hervelous®, in Central and Eastern Europe.

Lupin and Mylan agreement to commercialise etanercept biosimilar

June 28, 2018

Lupin and Mylan announce agreement to commercialise etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and Asia.

Results from infliximab biosimilar study released by Amgen

June 27, 2018

Amgen releases results of Phase III study of infliximab biosimilar, revealing no clinically meaningful differences to Remicade®.

LY | TN | Celltrion’s infliximab biosimilar launches in Libya and Tunisia

June 25, 2018

Celltrion launches infliximab biosimilar in Libya and Tunisia. The product will be distributed through Celltrion’s local partner Hikma Pharmaceuticals and is part of Celltrion’s overall plan to expand sales networks across Africa and into the Middle East.

US | Grassley and Klobuchar urge FTC to investigate Humira settlements

June 22, 2018

US Senators Chuck Grassley and Amy Klobuchar urge FTC to investigate ‘pay-for delay’ settlements, in particular AbbVie’s Humira settlements, for anti-competitive behaviour.  Of particular concern is investigating whether these settlements are keeping biosimilars out of the hands of patients.

US | Celltrion resubmits application for marketing approval of trastuzumab biosimilar

June 17, 2018

Celltrion resubmits application for marketing approval of trastuzumab biosimilar to the FDA. This follows CRLs from the FDA related to the February warning letter regarding Celltrion’s manufacturing facility in South Korea.

RA | Results of switching studies reported by Sandoz

June 15, 2018

Sandoz reports results of long term switching studies for biosimilars Zessly®(infliximab) and Erelzi® (etanercept) in RA.

Phase III clinical trials of ASART-2 announced

June 15, 2018

Biocad announces phase III clinical trials of ASART-2, biosimilar infliximab, reveal non-inferiority to Remicade at week 54.

UK | Pertuzumab rejected for treatment of early breast cancer

June 15, 2018

The National Institute for Health and Care Excellence (NICE) rejects pertuzumab for adjuvant treatment of early breast cancer. The draft guidance reports that the drug may not extend patient’s lives and is not cost effective.

Sandoz biosimilars Zessly® and Erelzi® results reported

June 15, 2018

Sandoz reports results of long term switching studies for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in RA.

Fresenius announces Ph III AmAb results

June 14, 2018

Fresenius reports the results of its Ph III studies for biosimilar adalimumab MSB11022 in moderate-to-severe chronic plaque psoriasis at the European League Against Rheumatism’s Annual European Congress of Rheumatology.

Celltrion reports results for infliximab

June 12, 2018

Celltrion reports preliminary results for new sub-cut formulation of infliximab.

US | Walgreen and Kroger file suit against J&J

June 12, 2018

Walgreen and Kroger also file suit against J&J in the Pennsylvania District Court, echoing Pfizer’s earlier (Nov 17) complaint alleging J&J has engaged in anti-competitive behaviour regarding the US sale of Remicade®.

US | FDA approves Mylan/Biocon’s Fulphila®

June 4, 2018

FDA approves Mylan/Biocon’s pegfilgrastim (Fulphila®) on Mylan’s resubmitted application.  This is a the first US Neulasta® biosimilar approved; the second US biosimilar approved from the Mylan/Biocon portfolio; and the tenth US biosimilar overall.  See related FDA media release here.

CA | Apotex’s Lapelga® is approved

June 1, 2018

Apotex achieves world first approval of pegfilgrastim biosimilar (Lapelga®) in Canada.

US | FDA rejects Amgen’s application for biosimilar trastuzumab ABP 980

June 1, 2018

FDA provides CRL rejecting Amgen’s application for biosimilar trastuzumab ABP 980, filed August 2017.  Amgen states “we do not expect this to impact our US launch plans.”

EU | Pfizer’s Trazimera® recommended for marketing authorisation by CHMP

June 1, 2018

CHMP recommends granting a marketing authorisation to Pfizer for its biosimilar trastuzumab (Trazimera®) for the treatment of breast and gastric cancer.

EU | CHMP adopts positive opinion for Sandoz AmAb

May 31, 2018

CHMP recommends granting marketing authorisation for 3 biosimilar AmAbs developed by Sandoz – HalimatozHefiya and Hyrimoz.

US | Celltrion resubmits aBLA for biosimilar Rituxan®

May 30, 2018

Celltrion resubmits its aBLA for CT-P10 (rituximab) biosimilar Rituxan®.  According to Celltrion, the FDA has resumed the approval procedure and Celltrion expects approval in 2018.

US | Celltrion announces intentions to refile aBLA for CT-P6 (trastuzumab)

May 30, 2018

Celltrion announces that it intends to refile its aBLA for CT-P6 (trastuzumab) in June 2018 with a view to obtaining approval in 2018.

EU | Lupin MA application for biosimilar etanercept accepted for EMA review

May 25, 2018

Lupin announces that its MA application for biosimilar etanercept has been accepted for review by the EMA.

EU | Sandoz’s Zessly® is approved

May 24, 2018

Sandoz announces it has received EU approval for Zessly® (inflliximab) for all originator indications.

US | FDA approes epoetin alfa biosimilar

May 15, 2018

FDA approves epoetin alfa biosimilar for the treatment of anaemia caused by chronic kidney disease, chemotherapy or use of zidovudine.

NeuClone announces preclinical results for biosimilar ustekinumab

May 10, 2018

Australia’s NeuClone announces preclinical results for its biosimilar ustekinumab, which are now scheduled for Ph 1 clinical trials in 2019.

 

Coherus announces preclinical studies ongoing for aflibercept

May 10, 2018

Coherus BioSciences discloses that preclinical studies will be ongoing in 2018 for CHS-2020 biosimilar aflibercept.

EU | US | Coherus releases Q1/2018 results and expectations

May 10, 2018

Coherus provides 2018 forecasts in its Q1/2018 results, including EU approval opinion by 28 June 2018, and US BLA acceptance by 3 June 2018. Commercial discussions ongoing.

Coherus confirms 2022 AmAb launch date

May 10, 2018

Coherus BioSciences confirms its 2022 target launch date for CHS-1420, biosimilar adalimumab.  Commercial partnering options are being considered.

Coherus announces expectation of clinical studies

May 10, 2018

Coherus announces it expects to initiate clinical studies for biosimilar ranibizumab CHS-3351 in 2018.

JP | Lupin files BLA for biosimilar etanercept (YBL113) in Japan

May 8, 2018

Lupin announced YL Biologics has filed a BLA for biosimilar etanercept (YBL113) in Japan. YL Biologics is a joint venture between Yoshindo and Kyowa (Lupin’s subsidiary), and YBL113 is the first biosimilar developed by the JV.

US | Amneal announces it has entered into a licensing agreement with mAbxience for it’s US bevacizumab

May 7, 2018

Amneal announces it has entered into a licensing agreement with mAbxience for its US biosimilar bevacizumab.  See subsequent mAbxience announcement here.

US | FDA rejects Celltrion BLA for biosimilars to trastuzumab and rituximab

May 4, 2018

Celltrion announces that the FDA has rejected its BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10).  The FDA complete response letter (CRL) followed a FDA warning letter received by Celltrion in January this year.  Celltrion promises that the BLAs will be resubmitted “relatively soon” and that approvals are expected “in 6 months after resubmission”.   The rejections were received 9 months after the BLAs were filed, and less than 2 months following the EU approval of Celltrion’s trastuzumab.

US | Coherus’ resubmission of BLA

May 3, 2018

Coherus announces resubmission of its BLA for biosimilar Peg-Filgrastim CHS-1701

US | Sandoz announces FDA rejection of BLA for biosimilar rituximab

May 2, 2018

Sandoz announces that the FDA has provided a CRL rejecting its BLA for biosimilar rituximab.

Results of Formycon/Bioeq Ph III studies released

May 2, 2018

Formycon/Bioeq announce interim positive results for their ph III studies for biosimilar ranibizumab FYB201.

EU | Mundipharma biosimilar trastuzumab launches in Europe

May 2, 2018

Mundipharma announces their biosimilar trastuzumab (in-licensed from Celltrion) is available in Europe. This is Mundi’s third biosimilar to be launched in EU, but the second biosimilar TmAb, following MSD’s launch in March 2018.

Biocon and Mylan add to their collaboration

April 26, 2018

Biocon announces Biocon and Mylan add insulin glargine 300 and pertuzumab to their collaboration.

US | CRL from FDA for Pfizer biosimilar trastuzumab released

April 23, 2018

Pfizer announces that it has received a CRL from the FDA for its BLA for biosimilar trastuzumab.  The FDA has highlighted the need for further technical information.

AU | Celltrion’s Truxima® approved by TGA

April 14, 2018

Celltrion’s rituximab biosimilar Truxima® is approved by the TGA. This is the second biosimilar approved in 4 months, following the approval of Sandoz’s Riximyo™ in December 2017.

EU | Mylan and Fujifilm announce AmAb deal

April 11, 2018

Mylan announces EU deal with Fujifilm (with other territories still under negotiation) relating to Fujifilm’s biosimilar adalimumab, filed in EMA on 18 May 2017 with approval expected “late 2018”.  Mylan’s existing partner Biocon will receive payments under the deal.

US | FDA rejects Celltrion BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10)

April 6, 2018

Celltrion announces that the FDA has rejected its BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10).  The FDA complete response letter (CRL) followed a FDA warning letter received by Celltrion in January this year.  Celltrion promises that the BLAs will be resubmitted “relatively soon” and that approvals are expected “in 6 months after resubmission”.   The rejections were received 9 months after the BLAs were filed, and less than 2 months following the EU approval of Celltrion’s trastuzumab.

AbbVie and Samsung announce global settlement

April 5, 2018

Samsung announces a royalty-bearing, global settlement with AbbVie enabling Samsung to launch its SB5 biosimilar adalimumab in Europe from 16 October 2018 and in the US from 30 June 2023.  The EU date is the same as AbbVie gave Amgen’s in its September 2018 global settlement, but the US date is 5 months later than Amgen’s licensed date of 31 Jan 2023.  SB5 is registered in EU as Imraldi® and in AU as Hadlima®.

US | Judge Stark dismissed with prejudice against Amgen

March 26, 2018

Coherus announces that Judge Stark (US District Court for the District of Delaware) dismissed with prejudice Amgen’s patent infringement complaint alleging infringement of US8,273,707.

 

EU | Sandoz announces CHMP opinion for Zessly®

March 23, 2018

Sandoz announces that it has received a positive CHMP opinion for biosimilar infliximab Zessly®.

EU | EMA’s CHMP adopts positive opinion for Amgen/Allergan’s trastuzumab biosimilar Kanjinti®

March 22, 2018

EMA’s CHMP adopted a positive opinion for ABP 980, Amgen/Allergan’s trastuzumab biosimilar Kanjinti®, 12 months after they announced filing the EC application.

EU | Mundi and Celltrion enter distribution and marketing agreement for Herzuma®

March 19, 2018

Mundi and Celltrion enter exclusive distribution and marketing agreement for biosimilar trastuzumab, Herzuma®, for 7 EU countries including UK, DE and IT.

KR | LG Chem obtains Korean regulatory approval for biosimilar etanercept

March 17, 2018

LG Chem (formerly LG Life Sciences) obtains Korean regulatory approval for biosimilar etanercept.  This is the second biosimilar etanercept approved in Korea (after Samsung’s 2015 approval of Brenzys), and follows the Japanese approval of LG Chem’s biosimilar etanercept in January this year.

TR | TRpharm reveals anticipation of biosimilar rituximab launch

March 14, 2018

TRpharm announces it is ready to launch biosimilar rituximab (developed by Dr Reddy’s) in Turkey, following approval on 30 Jan 2018.

EU | Ontruzant® launched as first TmAb biosimilar in Europe

March 9, 2018

Merck launches the first TmAb biosimilar in Europe by selling the product developed by Samsung Bioepis (SB3) as Ontruzant® in the UK.

US | Cadila plans an aBLA for biosimilar pegfilgastim

March 2, 2018

Cadila announces it intends to file an aBLA for biosimilar pegfilgastim by end of 2019.

Celltrion announces potential pembrolizumab biosimilar

February 14, 2018

Celltrion announces it has begun development of a pembrolizumab biosimilar. Merck’s patents for this product are set to expire in 2028.

EU | Celltrion’s Herzuma® approved by EC

February 13, 2018

EC approves Celltrion’s Herzuma® (biosimilar trastuzumab), 2 months after the positive opinion from the CHMP on 14 December, 2017.  This is Celltrion’s third EU approval and the second EU biosimilar trastuzumab approved in 3 months.

EU | JP | Lupin intends to file application in EU and JP for biosimilar etanercept

February 10, 2018

Lupin declares its intention to file an application in the EU and JP for biosimilar etanercept in July 2019.

EU | Refiling of MA for pegfilgrastim announced

February 3, 2018

Gedeon Richter announces refiling of MA for pegfilgrastim, following the completion of further clinical trials. GR withdrew its previous application in Dec 2016.  See Stada subsequent announcement here.

AU | TGA approves Hadlima®

January 24, 2018

The second biosimilar AmAb, Samsung Bioepis’ Hadlima®, is registered on the ARTG in 2 different dosages.

Pfizer releases results for PF-05280586

January 24, 2018

Pfizer announces positive top line results for PF-05280586, biosimilar to Rituxan/MabThera.

US | Declaration of patent invalidity

January 23, 2018

US Court of Appeals (Fed Cir) affirms patent invalidity.

CN | GE builds FlexFactory facility in China

January 23, 2018

GE announces it is building a FlexFactory (single use technology with 2 x 2000L bioreactors) facility in China for Clover, which is expected to be up and running by the end of 2018. Clover intends to manufacture biosimilar etanercept for the Chinese market there.

US | Celltrion and Teva commence proceedings for trastuzumab patents

January 19, 2018

Celltrion and Teva commence proceedings in District Court (Northern District of California) seeking DJ that 38 patents relating to trastuzumab are invalid, unenforceable and/or not-infringed.  This follows Celltrion/Teva’s US ABLA filing for biosimilar trastuzumab in late July 2017, and subsequent patent dance, and will test the boundaries of the availability of “DJ-within ABLA”.

JP | Mochida biosimilar etanercept approved in Japan

January 19, 2018

Mochida receives approval for the first biosimilar etanercept in Japan, developed in Japan in collaboration with LG Chem, to be distributed in Japan by Ayumi.  The application took approximately 11 months to be approved by the PMDA.

EU | Amgen and Allergen announce first EU approval of bevacizumab

January 18, 2018

Amgen and Allergan announce the first EU approval of biosimilar bevacizumab, to be marketed as Mvasti®.  Their application was filed with EMEA on 2 Dec 2016

US | Xbrane’s Phase III clinical trial for Xlucane® approved

January 18, 2018

FDA approves Xbrane’s Phase III clinical trial for a biosimilar ranibizumab candidate Xlucane®.  Xbrane expects to enrol approximately 600 patients in 16 countries with the first patient expected in March 2019.

CN | JP | US | Alteogen announces completion of pre-clinical studies of aflibercept

January 17, 2018

Korean Biosimilar company Alteogen announces completion of pre-clinical studies relating to ALT-L9, biosimilar aflibercept, and that it intends to file an investigational NDA with the US in 2018.  It also intends to roll out aflibercept in Japan (through partner Kissei Pharmaceutical) and China in 2022 “when the patents of the brand-name drug lapse”.

Kissei announces positive Ph III darbepoetin results

January 17, 2018

Kissei announces positive Ph III trials for JR131, biosimilar darbepoetin, with a view toward regulatory filing in 2018.

US | FDA accepts Sandoz’s AmAb for review

January 16, 2018

Sandoz announced the FDA has accepted for review its application under s351(k) for biosimilar adalimumab.   

JP | Genentech sues Sandoz and Kyowa Hakko Kirin

January 14, 2018

Genentech has sued Sandoz and Kyowa Hakko Kirin (Sandoz’s exclusive distributor) in Japan, alleging the sale of biosimilar RmAb (Rixathon®/Riximyo®) infringes 3 Genentech patents. Rixathon®/Riximyo® was approved in JP in Sep 2017.

AbbVie confirms it does not expect AmAb biosimilar competition until 2022

January 11, 2018

At the JP Morgan conference, Richard Gonzalez, (chairman of the board and CEO of AbbVie) confirms that AbbVie does not expect biosimilar competition for Humira® until 2022.

US | Teva and Celltrion file DJ action against rituximab patents

January 11, 2018

Teva and Celltrion file DJ action in the District Court (Northern District of California) against 37 rituximab patents alleging they are invalid, unenforceable and/or not-infringed. FDA accepted Celltrion’s ABLA on 27 June 2017, and the parties entered a patent dance.  On the same day, parallel proceedings were also filed in the same Court relating to (some overlapping) 38 patents to trastuzumab.

RU | Biocad’s biosimilar infliximab approved

January 10, 2018

Biocad obtains approval for its biosimilar infliximab in Russia.

Amgen discloses cetuximab biosimilar under development

January 10, 2018

Amgen discloses at JP Morgan Healthcare Conference that it is in process development for a cetuximab biosimilar.

NeuClone confirms ongoing development of biosimilar ustekinumab

January 8, 2018

Australia’s NeuClone confirms ongoing development of biosimilar ustekinumab, which is on target to enter Ph I trials in 2018.  Read more

Neuclone discloses development of biosimilar denosumab

January 8, 2018

Australia’s Neuclone discloses the 5th product in its pipeline is biosimilar denosumab, which is at the pre-clinical stage.

IN | Glenmark launches biosimilar AmAb in India

January 4, 2018

Glenmark announces the launch of biosimilar adalimumab (developed by Zydus, marketed as Adaly®), in India.

Mylan and Momenta announce aflibercept deal

January 3, 2018

Mylan and Momenta announce deal relating to the development of M710, biosimilar aflibercept.  Pivotal clinical trials are planned for early 2018.

2017

AU | Roche sues Sandoz for Riximyo®

December 21, 2017

Roche has sued Sandoz in the Federal Court in Sydney over its recent approval of Riximyo®, alleging infringement of 5 patents: AU2008207357, 761844, 2005211669, 2009201403, and 2007242919.

US | Lxifi® approved by FDA for treatment

December 13, 2017

FDA approves biosimilar infliximab, Ixifi® for the treatment of patients with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriosis.

US | Mylan/Biocon trastuzumab biosimilar Ogivri® approved

December 3, 2017

FDA approves Mylan/Biocon trastuzumab biosimilar Ogivri® for all “on-label” indications.  This is the first US approved trastuzumab biosimilar, and Mylan’s first US biosimilar approved.

AU | AU Gov’t biosimilar initiative results in changes to PBS listing of Brenzys®

December 1, 2017

The Australian government’s biosimilar uptake initiative results in changes to PBS listing for Samsung’s Brenzys® in Australia. “A” flagging (substitution at the pharmacy level) remains unchanged.

AU | Erelzi® approved in Australia

November 30, 2017

Sandoz’s biosimilar etanercept (Erelzi®)  approved in Australia in 3 dosages, the second approved biosimilar etanercept.

AU | Sandoz’s Riximyo® approved in Australia

November 30, 2017

Sandoz’s biosimilar rituximab, Riximyo® approved in Australia, following its approval in Europe 5 months earlier.

US | Formycon announces intentions to market biosimilar ranibizumab

November 28, 2017

German Formycon announced it intends to bring biosimilar ranibizumab to the US market in 2020 with commercialisation partner Bioeq (JV between Santo and Polpharma).

IN | Biocon/Mylan launches Krabeva® (bevacizumab) in India

November 23, 2017

Biocon launches Krabeva®, biosimilar bevacizumab, in India. Read more

EU | Samsung Bioepis receives regulatory approval for Ontruzant®

November 19, 2017

Samsung Bioepis receives regulatory approval for EU’s first biosimilar trastuzumab, Ontruzant® (to be marketed by MSD) for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

US | Roche sues Pfizer for trastuzumab

November 17, 2017

Roche sues Pfizer in District Court of Delaware, alleging infringement of 40 patents, the first US lawsuit involving trastuzumab.

US | Amgen launches Enbrel Mini® in the US

November 17, 2017

Amgen announces US launch of new ENBREL Mini® single-dose prefilled cartridge with AutoTouch® reusable autoinjector.

EU | Amgen/Allergan announce EMA’s CHMP has adopted a positive opinion for ABP215 (bevacizumab)

November 10, 2017

Amgen/Allergan announce the EMA’s CHMP has adopted a positive opinion for ABP 215, biosimilar to Avastin® (bevacizumab) for the same indications as the originator. Read more

EU | EMA approves Boehringer Ingelheim’s Cyltezo®

November 10, 2017

EMA approves BI’s Cyltezo® (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases in adults and children.

US | Janssen withdraws suit for patent infringement

November 10, 2017

Janssen withdraws suit against Samsung Bioepis filed in the District Court of New Jersey for patent infringement under the BPCIA in May 2017.

KR | Samsung Bioepis Samfenet® approved by MFDS for treatment

November 9, 2017

Samsung Bioepis announces that Samfenet®, biosimilar trastuzumab is approved by MFDS (South Korea) for the treatment of metastatic breast cancer, early-stage breast cancer and metastatic gastric cancer.

AU | TGA approves Amgevita®

November 9, 2017

The first biosimilar adalimumab, Amgen’s Amgevita®, is registered on the ARTG in 3 different dosages.

Boehringer Ingelheim publishes results from AmAb switching study

November 9, 2017

BI publishes results from switching study showing efficacy and safety maintained in patients who switched from Humira® to biosimilar Cyltezo®.

Pfenex ceases development of biosimilar banibizumab and pegfilgrastim

November 9, 2017

During its Q3/17 earnings update, Pfenex reports that it has ceased development of PF582 (biosimilar ranibizumab) and PF529 (biosimilar pegfilgrastim) due to resource constraints.  Pfenex reports during its Q3/17 earnings update that it has ceased development of PF582 (biosimilar ranibizumab) and PF 529 (biosimilar pegfilgrastim) due to resource constraints.

EU | Mylan refiles EU applications

November 7, 2017

Mylan refiles EU applications for biosimilar pegfilgrastim and trastuzumab.

Coherus publishes Ph III AmAb results

November 7, 2017

Coherus publishes phase 3 studies on proposed biosimilar adalimumab, CHS-1420.

Hexal publishes new AmAb study

November 7, 2017

Hexal/Parexel publishes results of PK, immunogenicity and safety studies relating to proposed adalimumab biosimilar GP2017. 

Cinfa Biotech anticipates further clinical data

November 1, 2017

Cinfa Biotech announces it will present further clinical data relating to B12019 at the 59th ASH Annual Meeting in Atlanta in December.

Pfenex announces ceased development of PF582

October 30, 2017

During its Q3/17 earnings update, Pfenex reports that it has ceased development of PF582 (biosimilar ranibizumab) and PF529 (biosimilar pegfilgrastim) due to resource constraints.

Results from switching studies released by Celltrion

October 29, 2017

Celltrion releases phase III results for switching studies comparing Biosimilar infliximab CT-P13 (marketed by Celltrion as Remsima® and by Pfizer as Inflectra®) and Remicade®, and phase I (open label) studies for sub-cutaneous infliximab.

EU | EU application for biosimilar pegfilgrastim accepted

October 27, 2017

Sandoz’s (refiled) EU application for biosimilar pegfilgrastim accepted for regulatory review by EMA. Sandoz received an FDA rejection in Jul 2016, and withdrew its earlier EMA application in Jan 2017.

RU | Biocad succeeds in rituximab patent challenge

October 27, 2017

Russian biosimilars company Biocad succeeds in Russian patent challenge relating to the use of rituximab for RA, and announces intention to launch in EU.

US | Genentech files further suit against Amgen (District of Delaware)

October 23, 2017

Genentech files a further suit under seal (District of Delaware) against Amgen, the third litigation existing between the parties relating to Amgen’s Mvasti® (biosimilar bevacizumab). The 25 patents at issue in this suit are the 24 patents included in the first Genentech suit and US patent 7,297,334. Read more

EU | Amgen withdraws EU application for Kyomarc® (bevacizumab)

October 17, 2017

Amgen withdraws EU application for Kyomarc® (biosimilar bevacizumab), for “marketing reasons”, but will continue with existing application for Mvasti®.  Read more

US | Complete Response Letter for Biocon’s pegfilgrastim released

October 10, 2017

FDA issues Complete Response Letter for Biocon’s pegfilgrastim. FDA has completed its review, but requires further CMC data.

US | Amgen files suit (Central District of California) same day Genetech commences suit (District of Delaware)

October 9, 2017

Amgen files suit (Central District of California) seeking DJ that 27 patents are invalid/unenforceable/not infringed by Amgen’s biosimilar bevacizumab Mvasti®. Read more.  On the same day, Genentech commenced suit in District of Delaware against Amgen relating to Mvasti®, alleging infringement of 24 patents and non compliance with the BPCIA disclosure requirements. Read more

EU | Cinfa Biotech’s application for B12019 accepted

October 4, 2017

EMA accepts Cinfa Biotech’s application for B12019, biosimilar pegfilgrastim.

US | AbbVie and Amgen settle AmAb dispute

September 28, 2017

Amgen and AbbVie settle global patent disputes regarding adalimumab, and Amgen secures a royalty-bearing, non-exclusive license to AbbVie’s Humira® IP.  Amgen’s license commences in the US on 31 Jan 2023, in most EU countries on 16 Oct 2018, and “on other dates in various countries in which AbbVie has intellectual property.”

AryoGen releases results of Ph III denosumab trials

September 26, 2017

AryoGen releases results of Phase III trials of biosimilar denosumab product.

KR | Samsung receives approval to launch AmAb in South Korea

September 20, 2017

Samsung says it has approval to sell biosimilar adalimumab in South Korea, but will delay launch due to patent expiry.

Samsung approved to commence Phase III clinical trials

September 20, 2017

Samsung is approved by the Ministry of Food and Drug Safety in South Korea to commence Phase III clinical trials for biosimilar ranibizumab.

EU | Samsung Bioepis receives positive CHMP opinion on Ontruzant®

September 15, 2017

Samsung Bioepis announces it has received positive CHMP opinion on Ontruzant®, biosimilar trastuzumab for early breast cancer, metastatic breast cancer and metastatic gastric cancer.  This is the first biosimilar trastuzumab recommended for EU approval.

EU | CHMP gives positive approval for Boehringer Ingelheim’s AmAb

September 15, 2017

BI receives positive CHMP opinon on Cyltezo®, biosimilar to adalimumab.  Approval is expected in Q4/17.

US | Amgen/Allergan’s bevacizumab Mvasti® approved in the US

September 14, 2017

Amgen/Allergan’s bevacizumab biosimilar (Mvasti®) (bevacizumab-awwb) approved in the US for colorectal, lung, brain, kidney and cervical cancer.  Read more 

Sandoz announces 51 week results for AmAb biosimilar

September 14, 2017

Sandoz announces at the EADV results from 51 week clinical study confirming that Sandoz’s biosimilar adalimumab matches Humira® in safety and efficacy profile.

Lupin secures external funding for etanercept program

September 13, 2017

Lupin secures external funding for its etanercept biosimilars program.

US | Sandoz’s application for rituximab accepted

September 12, 2017

FDA accepts Sandoz’s s351(k) application for rituximab.

US | BLA for biosimilar filgratism accepted

September 11, 2017

FDA accepts Adello Biologic’s BLA for biosimilar filgrastim.

Pfizer Phase III study for TmAb candidate announced

September 9, 2017

Pfizer announces positive findings in pivotal Phase III study for TmAb candidate PF-05280014 at ESMO 17.

Phase III data on Amgen/Allergan biosimilar trastuzumab released

September 9, 2017

Amgen/Allergan present Phase III data on biosimilar trastuzumab ABP 980 at ESMO 2017.

US | PTAB denies institution of Coherus’ IPR petitions

September 7, 2017

PTAB denies institution of Coherus Biosciences’ 4 IPR petitions against AbbVie’s 9,085,619 relating to the Humira® formulation.

US | FDA releases Form 483 addressing inspections of the Celltrion Incheon

September 6, 2017

FDA releases Form 483 raising 12 issues arising from the May/June inspections of the Celltrion Incheon biologics manufacturing facility, where Celltrion and Pfizer/Hospira’s biosimilar Inflectra® (infliximab-dyyb) is made.

US | FDA extends deadline on application for Mylan/Biocon trastuzumab biosimilar

September 2, 2017

FDA extends its decision deadline by 3 months on a s351(k) application for MYL-1401O, Mylan and Biocon’s trastuzumab (Herceptin) biosimilar.  Final decision is now expected by 3 Dec 2017.

US | Samsung Bioepis files petitions against Genentech trastuzumab patents

August 30, 2017

Samsung Bioepis has filed three petitions seeking joinder with Hospira’s IPR against key Genentech trastuzumab patents (IPR2017-01958 against 6,627,196 patent; IPR2017-01959 against 7,371,379, and  IPR2017-01960 against  7,892,549).  Hospira’s petitions against the same patents (IPR2017-00804, IPR2017-00805, and IPR2017-00737) were instituted by the Board.

US | FDA approves Cyltezo®

August 29, 2017

Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for Cyltezo® (adalimumab-adbm), a biosimilar to Humira®.  This is the first biosimilar from BI to be FDA approved.  According to the release:

  • Cyltezo® is not yet commercially available due to the active patent litigation between Boehringer Ingelheim and AbbVie.

  • EMA is expected to provide an opinion on BI’s EU application in 2017.

EU | EMA approves Imraldi®

August 24, 2017

Imraldi®, Biogen/Samsung’s adalimumab biosimilar approved in the EU.

CA | Sandoz launches Erelzi® in Canada

August 21, 2017

Sandoz launches Erelzi® in Canada.

EU | Biocon/Mylan withdraw EU applications

August 16, 2017

Biocon/Mylan withdraw EU applications for biosimilar trastuzumab & pegfilgrastim.

US | AbbVie commences BPCIA proceedings against Boehringer Ingelheim

August 2, 2017

AbbVie commences BPCIA proceedings against Boehringer Ingelheim for Humira® (adalimumab) biosimilar in the District Court of Delaware, alleging infringement of 8 patents: (8,926,975; 9,018,361; 9,090,867; 9,096,666; 9,255,143; 9,266,949; 9,272,041; and 9,546,212), a subset of the 74 listed under § 262(l)(3)(C) and § 262(l)(7).  Two of the patents in suit overlap with the 10 patents in suit in the earlier Delaware proceedings commenced against Amgen in August 2016 (8,663,945; 8,911,964; 8,916,157; 8,961,973; 8,986,693; 9,096,666; 9,220,781; 9,272,041; 9,359,434; and 9,365,645) which has been set down for hearing on 4 November 2019.   AbbVie alleges those 10 patents are a subset of 61 patents in dispute, the remainder of which could be addressed in phase 2 BPCIA litigation.

EU | Celltrion and Mundipharma disclose financial impact of Truxima®

August 1, 2017

Celltrion/Mundipharma claim their biosimilar rituximab (Truxima®) has 30% of total EU market due to rapid growth.

AU | Merck’s Renflexis® becomes PBS listed

August 1, 2017

Merck’s biosimilar infliximab (Renflexis®), co-developed with Samsung Bioepis, is the second biosimilar to be PBS listed in Australia.

US | Amgen and Allergan files BLA for biosimilar trastuzumab

July 31, 2017

Amgen and Allergan announce BLA filing for ABP980, biosimilar trastuzumab.

US | FDA reviews Celltrion & Teva BLA for biosimilar Herceptin®

July 31, 2017

Celltrion & Teva announce the FDA has accepted for review their BLA for CT-P6, biosimilar Herceptin® (INN: trastuzumab).

Boehringer Ingelheim commences AmAb interchangeability studies

July 28, 2017

BI commences interchangeability studies between biosimilar BI695501 and Humira 40mg/0.8ml, with the results expected in second half of 2019.

US | PTAB institutes IPR on Hospira requests for trastuzumab

July 27, 2017

PTAB instituted IPR on 3 of Hospira’s 5 IPR requests relating to trastuzumab.  The Board instituted IPR of the following patents: 7,371,379 (IPR2017-00805), 6,627,196 (IPR2017-00804), and 7,892,549 (IPR2017-00737). IPR was denied against 7,892,549 (IPR2017-00739) and 7,846,441 (IPR2017-00731).

US | Samsung Biopeis launches Renflexis®

July 24, 2017

Samsung Biopeis launches Renflexis® , biosimilar to J&J’s Remicade® in the US following its April approval in the US.

Korean BIOCND plans completion of clinical trials

July 21, 2017

Korean BIOCND shares its plans to complete the phase 1 clinical trials of Lucentis biosimilar (BCD 300) by the end of 2017 and then will seek a partner.

Celltrion to commence PH I clinical trials for bevacizumab in South Korea

July 17, 2017

Celltrion to commence ph 1 clinical trials for biosimilar bevacizumab in South Korea. Read more

US | Mylan’s biosimilar trastuzumab recommended for FDA OCAC approval

July 13, 2017

Mylan’s biosimilar trastuzumab goes before the FDA Oncology Drugs Advisory Committee in the afternoon session on 13 July 2017, and receives unanimous recommendation for approval by FDA OCAC.

US | FDA approves Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis

July 13, 2017

Janssen announced that the FDA has approved Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis.

US | Amgen/Allergan bevacizumab recommended for approval by FDA ODAC

July 13, 2017

Amgen/Allergan’s biosimilar becvacizumab recommended for approval by FDA ODAC. Read more 

US | Amgen BmAb before FDA Oncology Drugs Advisory Committee

July 13, 2017

Amgen’s biosimilar BmAb goes before the FDA Oncology Drugs Advisory Committee in the morning session on 13 July 2017. Read more

US | Teva/Celltrion’s aBLA accepted

June 29, 2017

FDA accepted Teva/Celltrion’s aBLA for CT-P10, biosimilar rituximab.

EU | EMA approves Erelzi®

June 27, 2017

Biosimilar etanercept (Erelzi®) approved in EU to treat multiple inflammatory diseases.

EU | CHMP gives positive opinion for Samsung’s AmAb

June 23, 2017

Imraldi®, Samsung’s adalimumab biosimilar (SB5) receives positive opinion from CHMP in EMA.

EU | EU approves Sandoz’s Rixathon®

June 19, 2017

EU approval received for Sandoz’s Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases.

US | FDA releases Response letter for CHS-1701

June 12, 2017

FDA sends Complete Response Letter regarding Coherus’ Neulasta biosimilar 351(k) application for CHS-1701.

US | Celltrion files BLA for Herzuma®

May 24, 2017

Celltrion files BLA for Herzuma®, biosimilar trastuzumab, to be marketed by Teva.

EU | EC accepts MA for Fujifilm’s AmAb

May 22, 2017

Fujifilm announces EC has accepted its MA for biosimilar adalimumab (FKB327) which Fujifilm filed in April 2017.   Clinical trials were conducted in RA and commenced in Dec 2014.

US | Janssen’s BPCIA proceedings against Samsung Biopeis commence

May 19, 2017

Janssen commences BPCIA proceedings against Samsung Bioepis in the District Court of New Jersey based on Samsung’s aBLA application for Renflexis® infliximab-abda, biosimilar to J&J’s Remicade®.

Results from second clinical study for biosimilar pegfilgrastim announced

May 17, 2017

Cinfa Biotech S.L announces positive top-line data from second clinical study for biosimilar pegfilgrastim (B12019).

Formycon is developing biosimilar ustekinumab

May 11, 2017

Germany’s Formycon is developing biosimilar ustekinumab, targeting 2023 for a US launch, and 2024 for EU launch.  Read more

US | Clinical trials of omalizumab approved

April 25, 2017

Glenmark announces FDA approval for Phase I clinical trials of omalizumab.

US | Samsung Biopeis’ Renflexis® approved by FDA

April 24, 2017

FDA approves Samsung Biopeis’ Renflexis® infliximab-abda, biosimilar to J&J’s Remicade® for all eligible indications.

CA | Health Canada grants NOC for Erelzi

April 4, 2017

Sandoz receives a Notice of Compliance for Erelzi® for the treatment of moderately to severely active rheumatoid arthritis in adults with or without methotrexate and for reducing signs and symptoms of active ankylosing spondylitis.  (Sandoz did not seek registration for psoriatic arthritis or plaque psoriasis).

AU | Brenzys receives ‘A flagged’ designation on the PBS

April 1, 2017

Samsung’s biosimilar etanercept, Brenzys, is listed on the PBS in Australia with “A” flagging enabling substitution at the pharmacy level

EU | Amgen files application for biosimilar trastuzumab

March 24, 2017

Amgen announces during a conference presentation that it has filed an application in EMA for biosimilar trastuzumab ABP 980.

US | EMA approves Amgevita®

March 23, 2017

EMA approves Amgen’s biosimilar adalimumab Amgevita® with a full indication set.  This is the first EU approval for biosimilar adalimumab.

Mylan enters global settlement with Genentech & Roche

March 14, 2017

Mylan announces global settlement with Genentech & Roche on TmAb with global licenses (excluding Japan, Brazil and Mexico).

UK | UK High Court hands down AmAb decision

March 3, 2017

UK High Court hands down decision in Samsung v Abbvie.

US | PTAB institutes IPR filed by Hospira against Genentech on bevacizumab patents

March 2, 2017

PTAB institutes IPR filed by Hospira against Genentech on bevacizumab patents IPR2016-01771 (Patent 7,622,115) and IPR2016-01837 (Patent 7,807,799) from requests filed 9 September 2016.

US | Judge Sleet dismissed Genentech’s suit filed 15 February 2017

March 2, 2017

Judge Sleet dismissed Genentech’s suit filed 15 Feb 17 (see below) under Fed Cir’s finding in Amgen v Sandoz.

EU | Mundi’s Truxima® approved by EMA

February 22, 2017

Mundi’s biosimilar rituximab (Truxima®, developed by Celltrion) approved by EMA, and intended for launch in the UK, Germany, Italy, Netherlands, Belgium, Ireland and Luxembourg.

US | Genentech sues Amgen in District Court of Delaware relating to bevacizumab

February 15, 2017

Genentech sues Amgen in District Court of Delaware alleging non compliance with BPCIA disclosure obligations in patent dance relating to bevacizumab.

EU | Sandoz’s EU application withdrawn

January 27, 2017

Sandoz withdraws EU application for Zioxtenzo, biosimilar pegfilgrastim.

EU | CHMP gives positive opinion for Amgen’s AmAb

January 27, 2017

CHMP (Committee for Medicinal Products for Human Use) for EMA gives positive opinion for Amgen’s biosimilar adalimumab.

2016

EU | Biograstim withdraws marketing authority

December 22, 2016

Biograstim’s withdrawal of marketing authority, declared by European Commission following voluntary withdrawal from CT Arzneimittel’s biosimilar representative Marketing-Authorisation holder (MAH).

EU | MA withdrawn for biosimilar pegfilgrastim

December 19, 2016

Gedeon Richter announces withdrawal of its MA for biosimilar pegfilgrastim.

EU | EMA approves Benepali® indication extension

December 16, 2016

Samsung Bioepis receives positive CHMP opinion for its  application for indication extension of Benepali® (etanercept) to include juvenile idiopathic arthritis and pediatric plaque psoriasis.

EU | Amgen/Allergan submit adalimumab application to EMA

December 2, 2016

Amgen/Allergan submit EMA application for biosimilar adalimumab.

US | Inflectra® commercially launched

November 25, 2016

Commercial (at risk) launch by Pfizer/Celltrion of Inflectra® (infliximab-dyyb).

US | Amgen and Allergan submit BLA for ABP 215 bevacizumab

November 15, 2016

Amgen and Allergan submit BLA for ABP 215, bevacizumab biosimilar. Read more

 

US | Sandoz plans further research

October 25, 2016

Sandoz indicates it plans to conduct further studies with a target of 2018 for further submissions to the FDA.

US | Coherus BioSciences filing for pegfilgrastim accepted

October 6, 2016

FDA accepts Coherus BioSciences 351(k) filing for pegfilgrastim.

CA | US | Teva and Celltrion enter marketing deal for commercialisation

October 6, 2016

Teva and Celltrion announce exclusive marketing deal under which Teva will commercialise Celltrion’s biosimilar rituximab and trastuzumab products in the US and CA.

EU | Samsung biosimilar trastuzumab under review

October 3, 2016

Samsung application for SB3, biosimilar trastuzumab accepted for review by EMA.

US | FDA approves Amgen’s Amjevita® (biosimilar adalimumab)

September 23, 2016

FDA approves Amgen’s biosimilar to adalimumab, Amjevita™ (adalimumab-atto), 11 months after Amgen’s application was filed.

CA | Health Canada approves Brenzys®

September 12, 2016

Brenzys®(SB4)  is the first biosimilar etanercept to be approved in Canada.

Pfizer and Pfenex’s partnership terminated

August 8, 2016

Pfizer terminates its relationship with Pfenex to develop PF582, biosimilar ranibizumab.

AU | TGA approves Brenzys®

July 22, 2016

Brenzys® (SB4) becomes the first biosimilar etanercept to be approved in Australia.

EU | Mylan/Biocon application on review

July 21, 2016

EMA accepts Mylan/Biocon application for biosimilar pegfilgrastm for review.

US | Application for Zioxtenzo® rejected

July 20, 2016

FDA rejects Sandoz’s application for Zioxtenzo®, biosimilar pegfilgrastim.

US | FDA releases a response to Zioxtenzo

July 19, 2016

Sandoz receives complete response letter from FDA relating to Zioxtenzo, Biosimilar pegfilgrastim, and is “working with the agency to address remaining questions.”

EU | EMA accepts Samsung’s AmAb application

July 18, 2016

Samsung announces the EMA has accepted for its review its application for adalimumab biosimilar.

US | FDA approves Erelzi®

July 13, 2016

FDA approves Sandoz’s Erelzi® for all indications included in the reference product label, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

US | FDA Advisory Committee to review Amgen’s biosimilar AmAb candidate

June 13, 2016

Amgen announces FDA Advisory Committee Meeting to review ABP 501 (biosimilar adalimumab).  FDA has set a Biosimilar User Fee target action date of 25 September 2016.

US | FDA Advisory Committee reviews Amgen adalimumab BLA

June 13, 2016

FDA’s Arthritis Advisory Committee reviews data supporting Amgen’s BLA for ABP 501 (biosimilar adalimumab).

EU | EMA approval for Flixabi®

May 30, 2016

Biogen/Samsung Biopeis receive EMA approval for Flixabi®, biosimilar Infliximab.

CN | Results of clinical trials of biosimilar omalizumab released

May 16, 2016

Sorrento releases results of Phase II and III clinical trials of biosimilar omalizumab, announcing the candidate STI-004 demonstrated clinical efficacy and safety.

US | FDA’s approval of Inflectra®

April 5, 2016

Pfizer/Celltrion received FDA approval for Inflectra®, biosimilar infliximab.

EU | Samsung Bioepis’ Flixabi® approved

April 1, 2016

EU’s CHMP gives green light for Flixabi®, Samsung Bioepis’ biosimilar infliximab.

UK | Samsung files UK revocation suit

March 24, 2016

Samsung Bioepis files suit in the UK to remove Abbvie patents regarding adalimumab.

EU | Filing for Zioxtenzo accepted

February 11, 2016

EMA accepts Sandoz’s filing for Zioxtenzo, biosimilar pegfilgrastim.

EU | EMA approves Benepali®

January 17, 2016

EMA approves Benepali®, biosimilar etanercept (SB4) for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. CHMP positive opinion was announced on 20 Nov 2015.  Samsung says it developed, tested and had its Benepali® approved in under 4 years.

MabTech’s successful clinical trials

January 11, 2016

MabTech announces successful Chinese Ph III clinical trials for Sorrento’s “biosimilar/biobetter” cetuximab STI-001, and infliximab STI-002.

MabTech announces successful Ph III trials of cetuximab

January 11, 2016

MabTech announces successful Chinese Ph III clinical trials for Sorrento’s “biosimilar/biobetter” cetuximab STI-001, and infliximab STI-002.

2015

CA | Grastofil® authorised

December 7, 2015

Health Canada confirms Authorisation of Filgrastim biosimilar Grastofil®.

AU | Hospira’s biosimilar infliximab becomes PBS listed

December 1, 2015

Hospira’s biosimilar infliximab becomes the first biosimilar infliximab to be PBS listed in Australia.

US | Amgen submits BLA for biosimilar adalimumab

November 25, 2015

Amgen submits BLA under s351(k) pathway for ABP 501 (proposed adalimumab biosimilar).

KR | Brenzys® approved in South Korea

September 7, 2015

Samsung Bioepis announces Brenzys® (SB4), biosimilar etanercept received approval in South Korea with launch intended late 2015/early 2016.

US | Launch of Zarxio®

September 3, 2015

Sandoz launches filgrastim biosimilar Zarxio® in US.

US | US approved to market Sandoz biosimilar Zarxio®

March 6, 2015

Sandoz biosimilar Zarxio® approved for US sale with the same indications as Neupogen®, and with a “placeholder” name “figrastim-sndz”.  This is the first approval of a biosimilar product in the US.

US | FDA accepts filing for Grastofil® and Neupogen®

February 17, 2015

Canadian drug manufacturer Apotex announces FDA has accepted for filing its Biosimilar application for Filgrastim (Grastofil®) along side previous patent Neupogen® within the US Marketplace.

US | Application for biosimilar Neulasta accepted

January 5, 2015

FDA accepts Apotex’s s351(k) application for biosimilar Neulasta.

2014

EU | Accofil® approved for distribution

September 18, 2014

US based manufacturer granted approval from EMA to distribute filgrastim biosimilar Accofil®.

 

CA | Celltrion/Hospira to market Remsima® and Inflectra®

January 15, 2014

CA approval for Celltrion/Hospira’s infliximab biosimilar products to be marketed as Remsima® and Inflectra®.

2013

EU | EMA welcomes Grastofil® in Europe

October 17, 2013

EMA welcomes Apotex’s biosimilar Filgrastim rendition, Grastofil®, throughout Europe.

EU | Remsima® and Inflectra® approved

September 10, 2013

Hospira/Celltrion’s infliximab biosimilar products approved in EU (Remsima® and Inflectra®).

2011

EU | Stada and Richter reveal collaboration deals for marketing

September 2, 2011

Stada and Gedeon Richter announce collaboration deals to develop and sell biosimilars rituximab and trastuzumab.

EU | EU marketing authorisation withdrawn by European Commission

April 20, 2011

European Commission (EC) withdraws EU marketing authorisation following Filgrastim Ratiopharm® MAH’s voluntary withdrawal.

2010

EU | Europe markets Nivestim®

June 25, 2010

A Biosimilar product of Filgrastim was approved by the European Commission and marketed across several European countries under the name of Nivestim®.

New Drug Submission by Tanvex

January 16, 2010

Tanvex submits New Drug Submission to Health Canada for biosimilar filgrastim.

2009

EU | Zarzio® approved for market

February 17, 2009

Sandoz’ EP2006 was approved by EMA for marketing in the European Union (EU) under the trade name Zarzio® as a biosimilar product to EU-approved Neupogen®.

EU | Hexal releases Filgrastim Hexal®

February 6, 2009

Hexal releases European biosimilar version of filgrastim, Filgrastim Hexal®.

2008

EU | Ratiopharm markets Ratiograstin®

September 30, 2008

In accordance to the 2014 European Public Assessment Report (EPAR) Certified by EMA, Ratiopharm marketed a biological medicine in late 2008 known as Ratiograstin®. This medicine is a biosimilar to the previously pattened EU authorised Filgrastim (Neupogen®).

Tevagrastim® authorised for market

September 29, 2008

The European Commission’s Directorate General for Enterprise and Industry granted Teva a Marketing Authorization for its human G-CSF product, Tevagrastim®.

EU | Biograstim® approved for market

September 15, 2008

New filgrastim drug Biograstim® given the green light for market authorisation and distribution by European Commission (EC) and EMA.