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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

Pearce IP BioBlast®: w/e 08 October 2021

October 11, 2021

27 Sep 21 | CA | 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.

02 Oct 21 | 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.

03 Oct 21 | 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.

04 Oct 21 | 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.

05 Oct 21 | 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.

07 Oct 21 | Xbrane Biopharma and AGC Biologics entered into an agreement to manufacture Xcimzane™ (certolizumab pegol) for clinical development.

08 Oct 21 | 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.

08 Oct 21 | AU | 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.

08 Oct 21 | US | 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.

Pearce IP BioBlast®: w/e 01 October 2021

October 5, 2021

27 Sep 21 | 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.

27 Sep 21 | CN | 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.

27 Sep 21 | JP | 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.

27 Sep 21 | 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.

28 Sep 21 | US | 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.

29 Sep 21 | US | 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.

30 Sep 21 | EU | Xbrane Pharma and STADA announced that the MAA for Xlucane™ (proposed biosimilar ranibizumab) has been submitted to the EMA.

01 Oct 21 | US, KR | Korea Biomedical Review reported that Celltrion has submitted an application for CT-P16 (proposed biosimilar bevacizumab) in the US and Korea.

01 Oct 21 | US | Coherus Biosciences announced that the FDA has accepted for review the BLA for CHS-201 (proposed biosimilar ranibizumab).

Pearce IP BioBlast®: w/e 24 September 2021

September 27, 2021

18 Sep 21 | 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.

18 Sep 21 | KR | 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.

20 Sep 21 | US | 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.

20 Sep 21 | US | AbbVie announced it has submitted the regulatory application for Skyrizi® (risankizumab) for the treatment of patients 16 years and older with moderate to severe Crohn’s Disease.

20 Sep 21 | 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.

23 Sep 21 | 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).

23 Sep 21 | 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.

23 Sep 21 | Merck announced that it has entered into a global settlement and license agreement with Pfizer resolving the ongoing dispute relating to Merck’s pneumoccocal conjugate vaccine products.

Pearce IP BioBlast®: w/e 17 September 2021

September 20, 2021

13 Sep 21 | 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.

13 Sep 21 | 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).

17 Sep 21 | EU | Alvotech announced that the EU’s CHMP has adopted a positive opinion recommending the approval of AVT02 (proposed adalimumab biosimilar).

18 Sep 21 | 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).

Pearce IP BioBlast®: w/e 10 September 2021

September 13, 2021

02 Sep 21 | US | 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.

06 Sep 21 | IN | Hetero announced that it has received emergency use approval from India’s DCGI to market its biosimilar tocilizumab for the treatment of COVID-19.

06 Sep 21 | AU | 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.

06 Sep 21 | AU | Australia’s TGA approved Gilead Sciences’ Trodelvy® (sacitizumab) for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer.

07 Sep 21 | 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.

07 Sep 21 | 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.

08 Sep 21 | 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.

09 Sep 21 | 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.

09 Sep 21 | 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.

10 Sep 21 | 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.

10 Sep 21 | AU | Australia’s TGA approved Kyowa Kirin’s Crysvita® (burosumab) for the treatment of X-linked hypophosphataemia.

Pearce IP BioBlast®: w/e 03 September 2021

September 6, 2021

26 Aug 21 | US | 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.

30 Aug 21 | AU | Australia’s TGA approved Celgene’s Reblozyl® (luspatercept) for the treatment of transfusion-dependent anaemia.

01 Sep 21 | UK | The UK’s NICE recommended UCB Pharma’s Bimzelx® (bimekizumab) as a treatment for plaque psoriasis in adults.

03 Sep 21 | UK | The UK’s NICE recommended Novartis’ Cosentyx® (secukinumab) as a treatment for plaque psoriasis in children aged 6-17 years.

03 Sep 21 | CN | China’s NMPA approved JW Therapeutics’ Relma-cel (relmacabtagene autoleucel) for the treatment of large B-cell lymphoma.

04 Sep 21 | 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).