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AstraZeneca and Merck (“MSD” outside North America) announced that China’s NMP has approved Lynparza® (olaparib) as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.
Alvotech and STADA announced the launch of Hukyndra® (100mg/mL, citrate free biosimilar adalimumab) in Switzerland. Alvotech reached a settlement with AbbVie in April 2022, enabling the launch of adalimumab across Europe, and STADA has since launched Hukyndra in several European countries from June 2022. Alvotech and STADA announced an exclusive partnership in November 2019 relating to six biosimilars, including adalimumab.
Korea Biomedical Review reported that Celltrion has successfully invalidated a Taiwanese Roche rituximab patent relating to the treatment of rheumatoid arthritis. Celltrion reported that it will now expand its label in Taiwan to include all indications of Rituxan®.
AVEO Oncology announced that the FDA has granted fast track designation to ficlatuzumab (its investigational humanized IgG1 mAb targeting hepatocyte growth factor) for the treatment of relapsed or recurrent head and neck squamous cell carcinoma.
Formycon disclosed that it is developing a biosimilar of Keytruda® (pembrolizumab), referred to as FYB206. The project is at an advanced preclinical stage, with GMP manufacturing planned for the end of 2022.
The EMA’s Biosimilar Medicines Working Party and the Heads of Medicines Agencies Biosimilars Working Group issued a joint statement (which was endorsed by the CHMP and the Biologics Working Party), confirming that biosimilar medicines approved in the EU are interchangeable with the reference product or with an equivalent biosimilar. Previously, interchangeability was permitted if the national regulatory agency allowed it, and EMA had not previously issued an official position on interchangeability. EMA confirmed that substitution at the pharmacy level will remain a matter for national governments. It is hoped that this harmonised approach will provide clarity for healthcare professionals prescribing biologics.
Sandoz announced the results of its Ph I/III trials of its biosimilar denosumab. Sandoz reported that the results confirm that the biosimilar matches the pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity of the reference product.
Pearce IP’s Naomi Pearce speaks to Kate Legge about the key IP strategies to enable the launch of biosimilars around the world, with a particular focus on Australia. Offering practical tips to success for biosimilar companies, this 14 minute PiPCast touches on:
- biosimilar FTO/clearance strategies, litigation, and settlement strategies;
- key lessons learned from the 11 AbbVie global royalty bearing deals relating to adalimumab (Humira®); and
- Australian biosimilar litigations.
Korea Biomedical Review reported that Prestige Biopharma has voluntarily withdrawn its EMA application for the HD201 (Tuznue®, biosimilar trastuzumab). Prestige received a negative opinion from the CHMP in May 2022, with the CHMP taking the view that the manufacturing process used for the commercial production of these medicines differed from that used during clinical testing. Prestige reportedly was not able to establish equivalence in a requested re-examination by CHMP. Prestige has represented that following withdrawal, it will supplement its data and resubmit with EMA this year.
Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), for the adjuvant treatment of adult and paediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.
Lupin announced that Health Canada has approved Rymti® (biosimilar etanercept) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondylarthritis (including ankylosing spondylitis and non-radiographic axial spondylarthritis), plaque psoriasis and paediatric plaque psoriasis.
Novartis announced that it will invest USD300 million in the creation of a fully integrated, dedicated facility for early development of biotherapeutics. The investment will be used to strengthen Novartis’ existing campuses in Basel and Schaftenau, and to create a dedicated biologics campus in Menges, Slovenia.
Merck reported that it presented data at the European Society for Medical Oncology (ESCO) Congress in Paris on 11 September, including:
- in patients with metastatic nonsquamous NSCLC, data from KEYNOTE-189 demonstrating KEYTRUDA plus pemetrexed (ALIMTA®) and platinum chemotherapy (cisplatin or carboplatin) had a five-year overall survival (OS) rate of 19.4% versus 11.3% for chemotherapy alone; and
- in patients with metastatic squamous NSCLC, results from KEYNOTE-407 showing the five-year OS rate for KEYTRUDA plus carboplatin-paclitaxel or nab-paclitaxel was 18.4% versus 9.7% for chemotherapy alone.
Separately, Eisai reported that would be presenting data on several trials on the combination of lenvatinib and pembrolizumab at the conference, including a late-breaking oral presentation of detailed results from the LEAP (Lenvatinib And Pembrolizumab) clinical program including the final analysis of the Phase 3 LEAP-002 trial as a first-line treatment for patients with unresectable hepatocellular carcinoma, as well as two mini-oral presentations with updated efficacy and safety data from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma, and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma.
Spectrum Pharmaceuticals announced that the FDA has approved its novel long-acting GCSF (LA-GCSF) ROLVEDON™ (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
AstraZeneca published the results of a 5-year follow up study of Lynparza® (Olaparib) with or without bevacizumab in newly diagnosed patients with advanced ovarian cancer. AstraZeneca reported that Olaparib with bevacizumab reduced the risk of death by 38% in HRD-positive patients compared to bevacizumab alone.
Biogen filed a sealed complaint against Sandoz and Polpharma for infringement of 28 Biogen patents in the District of Delaware relating to Sandoz’s biosimilar natalizumab (Tysabri®). Whilst the complaint was accepted under seal, Biogen was ordered to file a redacted complaint by 19 September 2022. Sandoz and Polpharma announced that they had entered into a licensing deal for Polpharma’s natalizumab biosimilar in September 2019, and the FDA accepted Sandoz’s ABLA for biosimilar natalizumab in July 2022.
Regeneron announced that the primary endpoints were met in two pivotal trials evaluating aflibercept 8mg with 12 and 16 week dosing regimes in diabetic macular edema and wet age-related macular degeneration.
Organon announced the release of the ‘Biosimilars: A global roadmap for policy sustainability’ setting out a number of priorities to achieve long-term sustainability of biosimilars in Australia, including:
- Ensuring alignment of financial incentives that benefit all key stakeholders, including physicians, pharmacists and patients
- Decreasing patient co-payments applied for biosimilars to enable cost savings not only for payers but for a broader range of stakeholders including patients
- Increasing multi-disciplinary decision-making regarding dispensing of biosimilars to ensure the best outcomes for the patients and best value for the healthcare system.
- Optimising existing pricing and reimbursement policy to mitigate the impact of erosion driven by mandatory discounts and considers the differences across therapeutic areas, the number of competitors and population size.
Lupin and DKSH announced that they have signed an exclusive licensing and supply agreement to market five of Alvotech’s biosimilar products in the Philippines. The biosimilars include AVT03 (biosimilar denosumab – Prolia® and Xgeva®), AVT05 (biosimilar golimumab/Simponi®) and AVT06 (biosimilar aflibercept/Eylea®) as well as two undisclosed proposed biosimilars for immunology and oncology.
Genentech and Samsung Bioepis filed a joint stipulation of dismissal in the District Court of Delaware in the bevacizumab BPCIA dispute, settling all claims and counter-claims. Genentech filed the suit against Samsung Bioepis in June 2020, alleging infringement of 14 patents relating to bevacizumab (Avastin®). No further details about the settlement agreement have been disclosed.
Yonhap News Agency reported that Celltrion’s ustekinumab biosimilar CT-P43 Ph III trials demonstrated comparable efficacy and safety to Janssen’s Stelara®. Data from the global 28-week study in 509 plaque psoriasis patients was presented at the European Academy of Dermatology and Venereology Congress 2022 in Milan, Italy.
Australia’s TGA approved Cipla/Alvotech’s 100mg/mL adalimumab biosimilar AVT02 (Ciptunec®/Ardalicip®) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hidradenitis suppurativa and uveitis. Cipla will supply Alvotech’s product in Australia and New Zealand under a partnership first announced in July 2019, which was expanded in March 2021 to include aflibercept, ustekinumab, denosumab and golimumab biosimilars.
German based biosimilars focussed company Formycon published its preliminary and unaudited financial results for the first half of 2022. Formycon reported a turnover of Euro 17.6 million in the first six months of 2022. The preliminary report does not include the purchase price allocation effects from the ATHOS transaction reported in May 2022 under which Formycon acquired rights to FYB202 (biosimilar Stelara®), 50% of the rights to FYB201 biosimilar Lucentis® and the operational development unit Bioeq GmbH. Formycon has six biosimilars in development, and is also working on the development of a COVID-19 drug FYB207.
The FDA approved Fresenius Kabi’s Stimufend® (biosimilar pegfilgrastim). Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Prestige Biopharma announced that it will acquire more shares of Prestige Biologics, to secure a total of 24.88% of the CDMO company. Prestige Biopharma reported that the new structure will allow the group to establish a full value chain with a 154,000 L, global-scale production facility.
Alvotech published its first half 2022 financial results, reporting a revenue growth to over $40 million compared to $2.0 million in the first half of 2021 due to recent launches of adalimumab (AV02) in Canada and Europe. The company has $128.4Min cash/equivalents and has current borrowings of $120.8M. Its R&D costs in the same period were 86.9M.
Alvotech “pipeline highlights” includes (amongst other things) an exclusive global licence agreement with BiosanaPharma regarding biosimilar omalizumab/to Xolair®, expanded partnership with Fuji Pharma, the completion and US submission of interchangeability studies for its high concentration adalimumab biosimilar, a US settlement with AbbVie relating to adalimumab and positive results from clinical studies on AVT04 (biosimilar ustekinumab/Stelara®). Alvotech also secured funding of approximately $185M through the OACB merger and PIPE financing.
Biocon announced that the FDA has issued 17 observations following its inspection of Biocon’s manufacturing facilities in Bengalaru, India (11 observations) and Johor, Malaysia (6 observations) relating to pre-approval inspections for bevacizumab, rh-Insulin and insulin aspart and a capacity expansion inspection for biosimilar trastuzumab. Biocon reported that the observations relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerised tools to aid risk assessment and investigations, and other procedural and facility upgrades. Reportedly, Biocon does not expect the observations to impact current supply.
Outlook Therapeutics announced that it has re-submitted its BLA for ONS-5010 LYTENAVA™ (bevacizumab-vikg, ophthalmic formulation) for wet AMD to the FDA. Outlook first submitted its BLA in March 2022, however withdrew it in May 2022 following requests from the FDA for additional information. Outlook reported that it has now provided the additional required information and is confident in the new application.
Merck announced that it will present data on several oncology medicines at the European Society for Medical Oncology (ESCO) Congress in Paris from 9-13 September, including relating to KEYTRUDA® (pembrolizumab) and PADVEV® (enfortumab vedotin).
Moderna has announced that it commenced proceedings against Pfizer and BioNTech in both the U.S. District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany last Friday seeking damages for patent infringement relating to the Pfizer/BioNTech COVID vaccine. Interestingly, Moderna is not seeking injunctions.
The lawsuit is reported to be based on three patent families Moderna filed between 2011 and 2016. The Moderna press release says:
“Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty® infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. This groundbreaking technology was critical to the development of Moderna’s own mRNA COVID-19 vaccine, Spikevax®. Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty®.”
This lawsuit is despite Moderna’s October 2020 pledge to not to enforce its COVID-19 related patents while the pandemic continued. This pledge was updated in March 2022, when “the collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world”. Moderna’s position is now that “while it would never enforce its patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92), Moderna expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license should they request one for other markets. Pfizer and BioNTech have failed to do so.”
Merck & Co is reportedly in negotiations to acquire Seagen Inc (previously known as Seattle Genetics, Inc), with negotiations presently having stalled due to a failure to agree on price. The acquisition could give Merck access to Seagen’s pipeline of antibody-drug conjugates (ADCs). Merck has previously announced strategic oncology collaborations with Seagen for two of its ADCs as well as Merck taking a USD1B equity stake in Seagen. Neither Merck nor Seagen have made any formal announcement about the purported acquisition.
Formycon announced that the European Commission has approved Ranivisio®, biosimilar to Lucentis®/ranibizumab developed by Bioeq (which is a joint venture between Formycon and Polpharma Biologics). Ranivisio is EC approved for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR) as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).
Earlier this month, Coherus announced the US approval of Cimerli™ with interchangeability designation, which Bioeq licensed to Coherus for the US. The Bioeq product was also approved in the UK in May 2017 as Teva’s Ongavia®.
Alvotech announced that it has commenced a confirmatory patient study for AVT03 (biosimilar to Prolia® and Xgeva®, denosumab). The objective of the study is to demonstrate clinical similarity of AVT03 to Prolia® in terms of efficacy, safety, immunogenicity and pharmacokinetics in postmenopausal women with osteoporosis. The results from this trial will be used to extrapolate to additional Xgeva® indications. Alvotech commenced phase I trials for denosumab in July 2022.
Novartis announced that it will spin off Sandoz into a new publicly traded standalone company. The new company will be headquartered in Switzerland and will be listed on the SIX Swiss Exchange, with an American Depositary Receipt program. Novartis reported that this separation will allow it to build a focused innovative medicines company. Novartis first announced that it would undertake a strategic review of the Sandoz division in October 2021, and in July 2022 confirmed that a decision on Sandoz’s future would be made by the end of 2022.
STADA published its first half 2022 financial results, reporting a 15% increase in adjusted group sales. Adjusted for currency fluctuations and special effects, earnings before interest, tax, depreciation and amortisation (EBITDA) improved by 23% to €386.5 million. STADA currently markets five biosimilar products, including Hukyndra® (biosimilar adalimumab) and Oyavas® (biosimilar bevacizumab).
Lupin announced that it has entered into an exclusive licensing agreement with I’rom Group for biosimilar denosumab in Japan. Under the agreement, I’rom and Lupin will together conduct clinical trials and obtain registration, and I’rom will then exclusively distribute and market the product in Japan.
Samsung Bioepis’ Byooviz® (biosimilar ranibizumab) was approved in Australia for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to choroidal neovascularisation (CNV) or choroidal neovascularisation (CNV) secondary to pathologic myopia (PM), and visual impairment due to macular oedema secondary to retinal vein occlusion (RVO). Byooviz was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019.
Samsung Bioepis obtained marketing approval for Byooviz in the US and EU in September 2021, Canada in March 2022, and in Korea in May 2022. It was reported in September 2021 that Samsung Bioepis took a licence for ranibizumab from Genentech from June 2022.
Amgen announced the results of a Ph III study evaluating the efficacy and safety of ABP959 (proposed eculizumab biosimilar) compared with Soliris® in adult patients with paroxysmal nocturnal haemoglobinuria. Amgen reported that the study met its primary endpoints and that the safety and immunogenicity profile of ABP 959 was comparable to Soliris.
Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved an expanded indication for Novartis’ Beovu® (brolucizumab). The approved indications now include diabetic macular oedema.
AU’s TGA approved Cipla’s FILPEGLA® (biosimilar pegfilgrastim) for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.
Fresenius Kabi announced that the EMA has accepted its MAA for MSB11456 (biosimilar tocilizumab). The application includes clinical data for both subcutaneous and IV administrations.
Celltrion announced that the EC approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer. The CHMP recommended the approval of Vegzelma in June 2022.
Samsung Bioepis and Organon announced that the FDA has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima™ (biosimilar adalimumab). The Hadlima 50mg/ml formulation was FDA approved in July 2019. Hadlima is expected to be launched on or after 1 July 2023, in accordance with its settlement with AbbVie announced in April 2018.
Formycon has reported that its ustekinumab biosimilar candidate FYB202 showed comparable efficacy and safety to Janssen’s Stelara in a Ph III clinical trial in plaque psoriasis patients. Formycon’s extended pharmacokinetics Ph I study has commenced. This follows Formycon’s acquisition of 100% of the rights to FYB202 from Athos, as previously reported.
Merck and Orna Therapeutics announced that they have entered into a collaboration agreement to discover, develop and commercialise multiple RNA programs, including vaccines and therapeutics in the areas of infectious diseases and oncology.
Merck’s PD-1 receptor blocker Keytruda is approved in the US and Europe for the treatment of a range of tumours, including melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin Lymphoma, urothelial carcinoma, oesophageal cancer, cervical cancer, renal cell carcinoma and triple negative breast cancer. Merck has now reported updates on several clinical trials, in which treatment with Keytruda® did not reach its primary endpoints:
- Phase 3 LEAP-002 trial investigating Keytruda® plus Eisai’s Lenvima® (lenvatinib), compared to Lenvima® monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). See the Merck update of 3 August here.
- Phase 3 KEYNOTE-921 trial evaluating Keytruda® in combination with chemotherapy (docetaxel) compared to chemotherapy alone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). See the Merck update of 3 August here
- Phase 3 KEYNOTE-412 trial evaluating Keytruda®with concurrent chemoradiation therapy (CRT) followed by Keytruda® as maintenance therapy for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC). See the Merck update of 20 July here
In each trial clinical improvements were shown but they did not meet pre-specified statistical significance. The safety profile from each trial was consistent with earlier studies.
Opthea announced a non-dilutive financing transaction for up to US$170 million from investment funds working with Launch Therapeutics to finance and advance the ongoing Ph III clinical trials and pre-commercialisation activities of OPT-302 (VEGF-C/-D ‘trap’ inhibitor) for wet age-related macular degeneration (wet AMD). Under the agreement, the funds will commit US$120 million in three instalments at fixed time points, with an option to commit an additional US$50 million. In exchange, Opthea will make a milestone payment after regulatory approval in a major market, followed by six annual fixed payments and variable success payments of 7% of net sales, with cumulative payments capped at four times the amount funded to Opthea.
Alvotech, Mylan, the Association for Accessible Medicines, and 42 professors of law, economics, business and medicine filed amicus curiae briefs in the US Supreme Court in support of Teva’s petition for a writ of certiorari. Teva is seeking review of the controversial divided panel of the Court of Appeal for the Federal Circuit decision in August 2021 in which Teva was found to have induced infringement of a narrow GSK method of treatment (MOT) patent relating to the use of Coreg® (carvedilol) to treat congestive heart failure, despite Teva’s CHF indication carve out. Teva and other companies have argued that this decision will threaten the future of ‘skinny-label’ for small molecules and large molecules.
Daiichi Sankyo and AstraZeneca announced that the FDA has offered accelerated approval to Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 mutations. Continued approval for this accelerated indication may be contingent upon verification in a confirmatory trial.
Roche announced that the FDA has approved the use of its Ventana® MMR RxDx Panel as the first immunohistochemistry companion diagnostic test to aid in identifying patients who may be eligible for treatment with Keytruda®. The panel is used to identify patients whose solid tumours are deficient in DNA mismatch repair (dMMR), and endometrial cancer patients whose tumours are proficient in DNA mismatch repair (pMMR).
ALX Oncology announced the initiation of Ph II trials of evorpacept (CD47 blocker) in combination with Erbitux® (cetuximab) and Keytruda® (pembrolizumab) for the treatment of refractory microsatellite stable metastatic colorectal cancer following at least two lines of systemic therapy.
The IPRs (inter-partes reviews) commenced by Mylan against Regeneron’s Eylea® patents 9,669,069 and 9,254,338 (instituted in December 2021) were heard by the PTAB together on 10 August 2022. The patents relate to Regeneron’s blockbuster product Eylea® (aflibercept) and analysts have reported that (at least) the ‘338 patent is likely to be invalidated, based on comments made by the PTAB during the proceedings.
Amgen announced that it has agreed to acquire ChemoCentryx, a biopharmaceutical company focused on auto-immune diseases, inflammatory disorders and cancer, for around $3.7 billion. ChemoCentryx markets Tavneos® (avacopan), a first-in-class treatment for multi-system autoimmune diseases involving small vessel inflammation.
In its earnings call on 4 August 2022, Coherus announced that it is developing a high concentration adalimumab formulation, which it intends to market following launch of its 50mg/ml citrate-free Yusimry™ formulation in July 2023. Coherus also shared its plans to capture “at least 10%” of the Humira® market in its first year of sales, which is capped by its current manufacturing capacity, although Coherus says it “has the potential to triple that capacity”.
Regeneron has filed a complaint against Mylan in West Virginia under the BPCIA alleging infringement of twenty-four patents relating to Eylea® (aflibercept). This follows the FDA’s acceptance for review of Mylan’s aBLA for its aflibercept biosimilar. Regeneron recently listed twenty-nine patents in the Purple Book as part of its patent dance with Mylan. Mylan previously sought IPR of several aflibercept patents.
Coherus Biosciences announced that the FDA has approved Coherus’ Cimerli™, a biosimilar to Genentech’s Lucentis® (ranibizumab). Cimerli is the third approved US biosimilar, but is the first to be approved for all five of Lucentis’ indications and to receive the interchangeable designation, resulting in twelve months interchangeability exclusivity.
Fresenius Kabi announced that the FDA has accepted for review Fresenius’ biosimilar candidate MSB11456 to Chugai’s Actemra® (tocilizumab). Actemra is presently the only tocilizumab product on the market in the US.
Janssen announced that the FDA has approved Stelara® (ustekinumab) for the treatment of paediatric patients aged six and over with active psoriatic arthritis (PsA). As there were insufficient paediatric patients with PsA to conduct clinical trials, the FDA based its approval on phase III trials in adults and children with plaque psoriasis and adults with PsA.
The Court of Appeals for the Seventh Circuit has agreed with the District Court, finding that AbbVie holding 132 US patents relating to Humira®, and settling litigation regarding the same, was not anti-competitive. The decision rejected the appeal filed by welfare benefit payors. The Court commented that there is no cap on the number of patents any one person can hold pertaining to a single subject, that every patent is presumed to be valid, that the appellants have not proved that AbbVie was using invalid patents to protect its monopoly, and that the settlements did not amount to cartel conduct.
A third revocation proceeding was commenced by Samsung Bioepis against a Fresenius Kabi adalimumab 50 mg/mL formulation patent AU2020204269 (‘269). The ‘269 patent covers a specific formulation of adalimumab with a specific buffer, sugar, surfactant and pH. These proceedings were commenced a day after the patent was granted (28 July 2022), following Samsung withdrawing its pre-grant opposition on 27 July (which it filed in December 2020).
Samsung commenced a revocation proceeding in June 2022 against a second, related 50 mg/mL adalimumab formulation patent. In 2019, Samsung also sought revocation of a first Fresenius adalimumab formulation patent, which resulted in Fresenius surrendering the patent in November 2019, the proceedings being dismissed by consent, and a costs order against Fresenius being made against Fresenius.
Celltrion Healthcare has reportedly filed an IND application to the FDA for a phase III clinical trial to demonstrate the interchangeability of its Yuflyma® (adalimumab) biosimilar and AbbVie’s Humira®. The trial will involve 366 patients with plaque psoriasis. Following Celltrion’s aBLA filing in late 2020 and its settlement with AbbVie in Q1 of 2021, Celltrion plans to launch in the US on 1 July 2023.
It has been reported that a Ph III clinical trial of Qilu Pharmaceutical’s biosimilar denosumab, QL1206, showed beneficial effects in post-menopausal Chinese women with osteoporosis and high fracture risk. After twelve months, subjects who received QL1206 showed significantly improved bone mineral density in the lumbar spine, total hip, femoral neck and trochanter compared to placebo.
Alphapharm (Viatris’ Australian subsidiary) has its etanercept biosimilar, Nepexto®, on the agenda for the November PBAC meeting. If the PBAC recommends that Nepexto is PBS-listed, it will become the third PBS-listed etanercept product after Pfizer’s Enbrel® and Arrow’s Brenzys®.
Prestige Biopharma announced an exclusive partnership with Intas and its affiliate Accord Healthcare to commercialise Prestige’s biosimilar bevacizumab in US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan. Prestige´s bevacizumab (HD204) is a biosimilar to Roche’s Avastin®. US and EU regulatory filings are expected in 2023.
Henlius Biotech announced that the TGA has approved Henlius’ trastuzumab biosimilar, which will be marketed in Australia by Cipla. The 150mg/vial product HANQUYOU has been sold as Zercepac™ in Europe and will be offered under trade names Tuzucip™ and Trastucip™ in Australia, covering all indications of the reference product.
Sandoz announced that the FDA has accepted its ABLA for a natalizumab biosimilar developed by Polpharma Biologics for all indications covered by the reference medicine Tysabri® including relapsing forms of multiple sclerosis (MS) – clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease in adults – and Crohn´s Disease. The EMA accepted a MAA for the same product earlier this month.
Sandoz announced that the FDA has accepted its sBLA for a high-concentration citrate-free formulation (100mg/mL) of Hyrimoz® (biosimilar adalimumab). The 50mg/mL formulation of Hyrimoz® was approved by the FDA in 2018 for the treatment of rheumatoid arthritis, juvenile idiopathic arthitis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
Alvotech announced that it has initiated a pharmacokinetic study for AVT03 (denosumab, biosimilar to Prolia®/Xgeva®). The study will assess the pharmacokinetics, safety and tolerability of AVT03 compared to Prolia® in healthy adult male subjects.
Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar candidate to Stelara®) for which Alvotech recently announced positive topline results; AVT04 (aflibercept/biosimilar candidate to Eylea®), golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.
Novartis published its financial results, reporting a 1% decrease USD (5% increase cc) in Q2 2022 sales over Q2 2021, and 3% decrease USD (5% increase cc) for Sandoz sales. Novartis confirmed that its strategic review of Sandoz is on track, and that it would provide an update at the latest, by the end of 2022.
Korea Biomedical Review reported that Celltrion has received approval from Poland’s Pharmaceutical and Medical Equipment Registration Office (URPL) for its IND for Ph III trials of CT-P47 (biosimilar to Actemra®, tocilizumab).
Erasca and Eli Lilly announced that they have entered into a clinical trial collaboration and supply agreement for Erbitux® (cetuximab). This agreement will support Erasca’s ongoing Ph I trials evaluating ERAS-601, its SHP2 inhibitor, with cetuximab for the treatment of triple wildtype metastatic colorectal cancer and HPV-negative advanced head and neck squamous cell carcinoma. Lilly will supply cetuximab to Erasca at no cost.
Hikma Pharmaceuticals announced that it has entered into a commercialisation agreement with Celltrion in relation to Celltrion’s YuflymaTM (biosimilar citrate-free adalimumab). Under the agreement, Hikma will gain exclusive commercialisation rights to YuflymaTM in all of its Middle East and North Africa (MENA) markets. Hikma has launched a number of Celltrion biosimilars: Truxima® (rituximab), Remsima® (infliximab) and Herzuma® (trastuzumab), with the launch of Remsima® SC (subcutaneous infliximab) in progress.
Polpharma Biologics announced that the EMA has accepted its MAA for its biosimilar natalizumab for highly active relapsing-remitting multiple sclerosis with the same dosing, presentation and indication as Tysabri®. Polpharma granted Sandoz commercialisation rights to Polpharma’s biosimilar under a global agreement announced in September 2019.
Roche reported that eight-year data from its Ph III trials of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy in HER2-positive early breast cancer demonstrates continued benefit of the combination in comparison to trastuzumab and chemotherapy alone. Roche reported a 28% reduction in the risk of recurrence or death in patients with lymph node-positive disease, and a safety profile consistent with previous studies.
Alvotech announced the expansion of its board of directors as part of its transition from private to publicly traded company in June 2022. Alvotech has welcomed four new board members, Lisa Graver, Arni Hardarson, Linda McGoldrick and Ann Merchant, joining existing board members Robert Wessman (founder and Executive Chairman), Richard Davies, Tomas Ekman and Faysal Kalmoua.
Byondis B.V. announced that the FDA has accepted its BLA for [vic-] trastuzumab duocarmazine (SYD985), a HER2-directed antibody-drug conjugate, for the treatment of patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC), with a PDUFA action date of 12 May 2023. This is Byondis’ first regulatory submission for SYD985 which is its lead program. In January 2018, the FDA granted fast track designation for SYD985, based on promising Phase I data for pretreated last-line HER2-positive MBC patients.
Overland ADCT BioPharma announced the dosing of the first patient in China in its second phase III clinical trials regarding Zynlonta® (loncastuximab tesirine-lpyl, a CD19-directed antibody drug conjugate), this time with rituximab in second-line or later, transplant ineligible patients with diffuse large B-cell lymphoma (DLBCL). The studies are intended to support sBLA filings in US and the PRC. Zynlonta® was granted accelerated approval by the FDA in April 2021.
Alvotech announced the initiation of its ALVOEYE clinical trials for AVT06, biosimilar to Eylea® (aflibercept) which is indicated for the treatment of adult patients with neovascular (wet) age-related macular degeneration (AMD). AVT06 is the third Alvotech biosimilar product to enter the clinic, and is one of eight products under development.
Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.
Janssen’s Stelara® (ustekinumab): requesting a General Schedule Authority Required listing of a new form for the treatment of patients with Crohn disease and chronic plaque psoriasis
AstraZeneca’s Enhertu® (trastuzumab deruxtecan): requesting a Section 100 Authority Required listing for the treatment of human epidermal growth factor receptor 2 positive (HER2) metastatic breast cancer in patients whose disease has progressed following treatment with at least one prior HER2-directed regimen in the metastatic setting or whose disease has progressed during or within 6 months following HER2-directed adjuvant treatment
AbbVie’s Skyrizi® (risankizumab): requesting General Schedule Authority Required listings for the treatment of severe Crohn’s disease and for complex refractory fistulising Crohn’s disease
BMS’ Opdivo® (nivolumab): requesting a s100 Authority Required listing for adjuvant treatment of patients who have undergone radical resection of muscle invasive urothelial carcinoma originating in the bladder or upper urinary tract and are at high risk of recurrence
Biogen’s Tysabri® (natalizumab): requesting removal of the clinical criterion which requires neurologists prescribing natalizumab under the PBS to be registered with the Tysabri Australian Prescribing Program
- Pfizer’s Zirabev® (biosimilar bevacizumab): reviewing positive recommendations not accepted by Pfizer
At the PBAC meetings 6 – 8 July, Australia’s PBAC considered a number of applications for biologic and biosimilar products, including:
Celltrion’s Yuflyma® (biosimilar adalimumab): requesting listing under the same conditions as Humira®
Roche announced that the FDA has accepted the BLA and granted priority review for Roche’s Lunsumio® (mosunetuzumab) (potential first-in-class CD20xCD3 T-cell engaging bispecific antibody) for the treatment of adults with relapsed or refractory follicular lymphoma who have received at least two prior systematic therapies. The FDA is expected to a make a decision by 29 December 2022.
Following Alvotech’s listing on the NASDAQ and NASDAQ First North growth market last month, the board of directors has approved an increase in its share capital by an amount of $270,721.67 through the issuance of 27,072,167 ordinary shares. The share capital increase was executed to facilitate the Company’s obligations (a) in relation to the public and private warrants assumed as a consequence of the business combination with Oaktree Acquisition Corp announced in December 2021, (b) under its management incentive plan.
Viatris announced that it was voluntarily recalling one batch of insulin glargine 100 units/mL, 3mL prefilled pens (batch BF21002895) due to the potential for the label to be missing on some pens. This recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens. The batch was manufactured by Biocon, and sold in the US between 4 April 2022 and 5 May 2022.
Xbrane Biopharma confirmed that it will resubmit a BLA for its biosimilar to Lucentis® (ranibizumab) this year. Xbrane previously announced that it would withdraw the BLA after receiving feedback from the FDA in May that additional information was required for the FDA to accept the BLA and initiate a review.
PDS Biotechnology announced that the FDA has granted fast-track designation to PDS0101 (novel T-cell HPV-specific immunotherapy) in combination with Keytruda® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
The results of a phase III study of Iranian biopharmaceutical company AryoGen Pharmed’s denosumab biosimilar Arylia in osteoporosis patients showed that its efficacy and safety were not inferior to Amgen’s Prolia®.
Shanghai Henlius Biotech announced that the IND for HLX53 (anti-TIGIT Fc fusion protein) has been accepted by China’s NMPA. HLX23 is being developed for the treatment of patients with advanced/metastatic solid tumours or lymphomas.
Regeneron announced that the FDA has accepted for review the sBLA for Eylea® (aflibercept) for a 16-week 2mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy. The FDA has set a target action date of 28 February 2023.
Daiichi Sankyo announced that it has submitted a sNDA to Japan’s Ministry of Health, Labour and Welfare for trastuzumab deruxtecan for the treatment of adult patients in Japan with HER2 low unresectable or recurrent breast cancer after prior chemotherapy.
Merck announced that the EC has approved Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection, as well as expanding the indications for Keytruda® in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) in adolescent patients aged 12 years and older.
EU’s CHMP adopted a positive opinion recommending a change to the existing indication for Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) to ‘Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two one or more prior anti HER2 based regimens’.
Samsung Bioepis filed a suit against Fresenius Kabi in the AU Federal Court, seeking to revoke AU2020201090 ‘Liquid pharmaceutical composition’ (‘090 patent) which was granted 2 days earlier, on the grounds of novelty, obviousness, lack of utility, lack of best method, lack of clarity and lack of support.
The ‘090 patent is related to Fresenius Kabi’s AU 2015263246 (‘246 patent), which Samsung sought to revoke in 2019. The proceedings were discontinued in early 2020 after Fresenius Kabi surrendered the patent, with Fresenius ordered to pay Samsung’s costs.
The recently granted ‘090 patent, like the earlier granted ‘246 patent, relates to a specific composition of adalimumab, including a histidine buffer, specified sugar and polysorbate.
There is a third granted family member (AU2018222887), which Samsung has not sought to revoke to date, nor has Fresenius asserted it against Samsung.
The CHMP recommended the approval of Celltrion’s Vegzelma® (bevacizumab/biosimilar to Avastin®) for the treatment of 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.
The CHMP recommended the approval of Midas Pharma’s 10mg/ml Ranivisio® (ranibizumab/biosimilar to Lucentis®) for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema or choroidal neovascularisation, and proliferative diabetic retinopathy.
AVEO Oncology announced that it has entered into a clinical trial collaboration and supply agreement with Eli Lilly to evaluate ficlatuzumab in combination with ERBITUX® (cetuximab) in the US and Canada in patients with recurrent or metastatic head and neck squamous cell carcinoma. This follows a similar engagement with Merck earlier in 2022 regarding Aveo’s clinical development plan for ficlatuzumab.
Following its 16 June 2022 listing of warrants and shares on the NASDAQ Alvotech debuted on the NASDAQ First North growth market on 23 June 2022, becoming the first dual US-Icelandic listed company. Alvotech’s current portfolio of eight products and product candidates represent an estimated total addressable market of over US$85 billion, based on estimated peak sales of the reference products.
Alvotech’s portfolio includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; aflibercept/biosimilar to Eylea®, denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.
Formycon published its Q1 2022 financial results, reporting sales and other earnings of EUR 8.2 million. Formycon also announced the addition of two biosimilar projects to its pipeline, FYB208 and FYB209, for undisclosed products. Late stage Formycon development programs include biosimilars to Lucentis® (ranibizumab), Stelara® (ustekinumab) and Eylea® (aflibercept). Formycon plans to launch its biosimilar to Lucentis® (ranibizumab) in the second half of 2022.
Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical have signed a commercialisation agreement for Amelivu®,biosimilar to Lucentis® (ranibizumab). Under the agreement, Samil is licenced to sell Amelivu® in Korea. Samsung Bioepis signed a settlement with Genentech in 2021 allowing it to market its ranibizumab biosimilar from June 2022. Amelivu®/Byooviz® has been approved in the EU, US, Canada and Korea, and was launched in the US in June 2022.
Innovent Biologics and Eli Lilly announced that the CDE of China’s NMPA has approved the sNDA for TYVYT® (sintilimab injection) in combination with cisplatin plus paclitaxel or cisplatin plus 5-FU chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Sandoz announced that the EMA has accepted its application for high concentration (100mg/mL) citrate-free product Hyrimoz® (biosimilar adalimumab). Sandoz’s application seeks approval for all AbbVie Humira® indications.
Alvotech announced that its shares and warrants began trading on the Nasdaq on 16 June under the new ticker symbols ‘ALVO’ and ‘ALVOW’ respectively, following the completion of the company’s business combination with Oaktree Acquisition Corp. II. The transaction was supported by a PIPE totalling approximately $175M, backed by top-tier investors.
Ordinary shares are also expected to commenced trading on the Nasdaq First North Growth Market in Iceland from 23 June 2022. Alvotech is expected to be the first dual-listed Icelandic company listed on both a US and Icelandic stock exchange.
Alvotech’s portfolio includes AVT02 (adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; aflibercept/biosimilar to Eylea®, denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.
Innovent Biologics and PT Etana Biotechnologies announced that the Indonesian Food and Drugs Authority has approved Bevagen® (bevacizumab biosimilar) for metastatic colorectal cancer (mCRC); locally recurrent or metastatic triple negative breast cancer (mTNBC); advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC); epithelial ovarian, fallopian tube, and primary peritoneal cancer (OC); and cervical cancer (CC). According to Innovent and Etana, Bevagen® may be “the first Chinese antibody drug to be marketed and locally produced in Southeast Asia”.
Merck announced that the FDA has accepted its sBLA for Keytruda® (pembrolizumab) as adjuvant therapy for stage IB-IIA non-small cell lung cancer following complete surgical resection.
Organon announced that it has entered into a licence agreement with Shanghai Henlius Biotech regarding biosimilars to Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14). Under the agreement, Organon has exclusive global commercialisation rights “except for China; including Hong Kong, Macau and Taiwan”. The agreement also includes an option for an exclusive licence for global commercialisation rights to a biosimilar to BMS’ Yervoy® (ipilimumab).
Samsung Bioepis presented data from its Ph III trials of SB12 (eculizumab biosimilar) in paroxysmal nocturnal hemoglobinuria at the European Hematology Association 2022, reporting that SB12 is bioequivalent to Alexion’s Soliris®.
Alvotech announced the launch of Hukyndra® (citrate-free 100mg/ml biosimilar adalimumab) in Europe by its partner STADA. The initial launch regions include France, Germany, Finland, and Sweden, with further launches scheduled “over the coming months”. Whilst Hukyndra® is the fifth biosimilar to be marketed by STADA, it is the first arising from its partnership with Alvotech which covers seven biosimilar products.
A new study sponsored by GSK presented at the ASCO annual meeting reported on a small trial of 14 patients with locally advanced mismatch repair-deficient rectal cancer. The researchers reported that 6 months of treatment with dostarlimab led to clinical complete responses in 100% of the patients, removing the need for chemotherapy, radiation or surgery.
Amgen announced that the FDA has approved a new indication for Riabni™ (biosimilar rituximab) – in combination with methotrexate, for adults with rheumatoid arthritis who have had an inadequate response to TNF antagonist therapies. Riabni™ is Amgen’s fifth approved US biosimilar, and was approved in December 2020 for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.
The PTAB instituted an inter partes review filed by Fresenius Kabi against US Patent 9,750,752 (‘752 patent) owned by Chugai Seiyaku Kabushiki Kaisha and Hoffman-La Roche. The ‘752 patent is directed at methods of treating giant cell arteritis by subcutaneously administering tocilizumab. This is the sixth IPR instituted by PTAB regarding tocilizumab patents arising from Fresenius Kabi challenges.
Biogen and Samsung Bioepis announced the launch of Byooviz™ (biosimilar ranibizumab) in the US. Biogen announced that Byooviz will be available at a discount of 40% compared to Lucentis®. Byooviz was developed under a partnership between Biogen and Samsung Bioepis, and this launch is the first US biosimilar arising from the partnership.
Civica announced that is has selected Profil as its clinical trial partner to support the development of its affordable insulin initiative. In March 2020, Civica announced its plan to manufacture biosimilar insulins glargine, lispro and aspart. Civica plans to set a maximum recommended consumer price of no more than $30 per vial, or $55 for a box of five pen cartridges.
Roche announced that Health Canada has approved Vabysmo® (faricimab) for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME). This is the first approved treatment in Canada for wet AMD and DME that targets both VEGF-A and Ang-2.
Lannett provided an update on its pivotal clinical trials of biosimilar insulin glargine. Lannett announced that half of the subjects have received the first two doses in healthy volunteer pharmacokinetics (PK) and pharmacodynamics (PD) study. No serious adverse events have been reported, with the study due to finish at the end of 2022. Lannett also announced that it plans to submit its BLA for the project in early 2023, with a potential launch in the first half of 2024.
Novartis announced that the FDA has approved Beovu® (brolucizumab) for the treatment of diabetic macular edema (DME). Beovu® is also indicated for the treatment of wet age-related macular degeneration.
Sandoz launched Act4Biosimilars a new initiative aimed at improving patient access to biosimilars by facilitating greater approvability, accessibility, acceptability and affordability. The mission of Act4Biosimilars is to increase biosimilar use by 30% in 30+ countries by 2030.
Outlook Therapeutics announced that it has voluntarily withdrawn its BLA for ONS-5010/LYTENAVA™ (proposed biosimilar bevacizumab) after the FDA requested additional information. Outlook Therapeutics announced that it is actively working to respond to the FDA’s request and plans to re-submit a revised BLA by September 2022.
Australia’s Generic and Biosimilar Medicines Association hosts 2022 Biosimilar Awareness Week with the key focus on delivering equitable access to affordable medicines to all Australians.
Amneal Pharmaceuticals announced that the FDA has approved its ABLA for Fylnetra™ (biosimilar pegfilgrastim). Fylnetra™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs. This is Amneal’s third biosimilar approved in the USA (following its filgrastim and bevacizumab biosimilars), which was developed in collaboration with Chicago based Kashiv Biosciences.
Alpine Immune Sciences announced that the FDA has removed the partial clinical hold placed on its NEON-2 trial evaluating davoceticept (first-in-class conditional CD28 costimulator and dual checkpoint inhibitor) in combination with pembrolizumab in adults with advanced malignancies. The partial clinical hold (now lifted) was implemented in March 2022 after a grade 5 serious adverse event leading to a patient’s death occurred.
The UK’s NICE published final draft guidance recommending Vabysmo® (faricimab) for the treatment of adult patients with wet age-related macular degeneration (AMD) or diabetic macular oedema (DMO).
Shanghai Henlius Biotech announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay for the commercialisation of Hanlikang® (biosimilar rituximab) and Hanquyou® (biosimilar trastuzumab) in Brazil.
Biond Biologics announced the first patients have been dosed in its Ph I trials of BND-22 (an Ig-Like Transcript 2 (ILT2) receptor blocking antibody) in combination with pembrolizumab or cetuximab being conducted in Israel and the US. BND-22 is being developed under an exclusive world wide licence with Sanofi.
The US District Court of Delaware has set down BMS’ patent infringement case against AstraZeneca regarding Imfinzi® (durvalumab) as a jury trial in April 2024. BMS filed a complaint against AstraZeneca in March 2022, alleging that AstraZeneca’s Imfinzi® (durvalumab) infringes eight of its patents relating to anti-PD-L1 antibodies.
Merck announced that it has received a positive opinion from the CHMP for its anti-PD-1 therapy Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment for adult and adolescent patients with stage IIB or IIC melanoma following complete resection. CHMP additionally recommended expansion of the Keytruda indications into advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients (12 years and older).
Days later Merck announced that the EC has approved Keytruda® (pembrolizumab) with chemotherapy as neoadjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early-stage triple-negative breast cancer at high risk of recurrence. Merck says this is the fifth approval for Keytruda in a breast or gynecologic cancer in the EU in less than a year.
The CHMP recommended refusing the marketing authorisations for Prestige Biopharma’s applications for trastuzumab biosimilars Tuznue® and Hervelous®. The CHMP stated that the manufacturing process used for the commercial production of these medicines differed from that used during clinical testing, and considered that ”the studies presented did not provide enough evidence to show that the commercially produced medicine will be biosimilar to the reference medicine”. Korea Biomedical Review reported that Singapore based, Kosdaq-listed Prestige Biopharma will appeal the decision.
Biocon Biologics and Viatris announce the launch of Abevmy® (biosimilar bevacizumab) in Canada. Abevmy® was jointly developed by Biocon and Viatris, and is indicated for metastatic colorectal cancer, locally advanced, metastatic or recurrent non-small cell lung cancer, platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer and malignant glioma-glioblastoma. This is the fourth Canadian biosimilar launched by Viatris.
Under the portfolio development agreement (which includes a “broad portfolio of biosimilars and insulin analogs”), Viatris has exclusive commercialisation rights in the U.S., Canada, Australia, New Zealand, EU and the European Free Trade Association countries, whilst Biocon has them in certain emerging markets. They share co-exclusive commercialisation rights in the rest of the world.
Korea Biomedical Review reported that Celltrion has submitted a global Ph III clinical trial plan for CT-P47 (biosimilar tocilizumab) to Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The global Ph III trial commenced in May 2022, and follows the phase 1 trial which commenced in July 2021.
Teva announced that the UK’s MHRA has granted marketing approval for Ongavia® (biosimilar ranibizumab), making the UK the first country in Europe to approve the product for the treatment of (wet) AMD. Ongavia® will be Teva’s first biosimilar commercialised in Europe, and the UK’s first Lucentis® biosimilar. The product is the result of a strategic agreement between Teva and Bioeq AG. Ongavia® is approved for the treatment of: neovascular (wet) age-related macular degeneration; visual impairment due to diabetic macular oedema (DME); proliferative diabetic retinopathy (PDR); visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); and visual impairment due to choroidal neovascularisation (CNV).
Korea Biomedical Review reported that Samsung Bioepis has received marketing approval for Amelivu® (biosimilar ranibizumab) in Korea. Amelivu® will be launched in Korea after June 2022 in accordance with Samsung Bioepis’ licence from Lucentis® developer Genentech. The Korean Biomedical Review reports that Samsung Bioepis may launch in other licensed regions (which includes the USA) following “after Genentech’s SPC expires”.
Alvotech announced positive top-line results from a 3 arm, parallel design study conducted in Australia and New Zealand regarding AVT04 (ustekinumab biosimilar), reporting that the study results demonstrate bioequivalence between AVT04 and Janssen’s Stelara®. Teva and Stada are Alvotech’s exclusive strategic partners for commercialising AVT04 in the US and EU respectively.
Alvotech announced that it will hold an Extraordinary General Meeting of shareholders to approve the pending business combination with Oaktree Acquisition Corp. II. (Oaktree) on 07 June 2022. Alvotech has filed the proxy statement/prospectus with the US SEC and the SEC has declared the Registration Statement on Form F-4 effective. On 7 December 2021, Alvotech and Oaktree announced that they had entered into a merger agreement for the creation of a publicly-traded global biopharmaceutical company.
JSR Life Sciences announced the launch of a new business division, Similis Bio. Similis Bio plans to operate a partnering program to help biopharmaceutical companies improve the efficiency and cost of biosimilar development programs.
Merck announced that it will present data from studies of six medicines and pipeline candidates in more than 25 cancers at the 2022 American Society of Clinical Oncology Annual Meeting in June. This will include data on Keytruda® (ustekinumab), Lenvima® (lenvatinib) and its investigational anti-LAG-3 therapy favezelimab.
Formycon and Athos KG announced closing of the acquisition by Formycon of 50% of the rights to FYB201 (biosimilar ranibizumab), 100% of the rights to FYB202 (biosimilar ustekinumab), together with Bioeq GMBH, which is described as its “long-time partner”. The total value of the deal is €650M.
Pfizer commenced patent infringement proceedings in the Federal Court of Australia against Samsung Bioepis, Merck, Organon and Arrow Pharmaceuticals in relation to AU2005280034 and the supply of etanercept.
AstraZeneca announced that the FDA has approved Enhertu® (trastuzumab deruxtecan) a HER2-directed antibody drug conjugate jointly developed and commercialised by AZ and Daiichi Sankyo, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
Opthea Limited presented data for OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in combination with ranibizumab for polypoidal choroidal vasculopathy at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting. Opthea reported that OPT-302 used in combination with ranibizumab achieved superior visual acuity gains and anatomic improvements compared to monthly ranibizumab monotherapy.
Korea Biomedical Review reported that Boditech Med has obtained approval in Korea for its AFIAS infliximab system. AFIAS infliximab is a therapeutic drug monitoring device used to measure infliximab levels in the blood and check for adverse reactions.
The Kennedy Institute (Oxford University) published the results of Ph IIb trials of adalimumab in Dupuytren’s disease. The researchers reported no related serious adverse events, and that the treatment was effective. Although the half-life of adalimumab is two or three weeks, researchers saw continued effects nine months after the last injection.
Merck announced that the EC has approved Keytruda® (pembrolizumab) in combination with chemotherapy (with or without bevacizumab) for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumours express PD-L1.
Korea Biomedical Review reported that Celltrion has a licence from AbbVie enabling the launch of Yuflyma® (Celltrion’s biosimilar adalimumab) in the US from July 2023. Celltrion expects to receive approval for Yuflyma® this year. Celltrion previously announced in February 2021 that it had completed patent settlements in the US and was approaching settlements in Europe.
Amgen released its Q1 2022 financial results, reporting a 6% increase in YoY revenues. Amgen reported a 12% increase in Prolia® (denosumab) sales, a 7% decrease in Enbrel® (etanercept) sales, a 2% increase in Amgevita™ (biosimilar adalimumab) sales and a 40% decrease in Kanjinti® (biosimilar trastuzumab) sales.
Merck announced that it received a positive CHMP opinion for its anti-PD-1 therapy Keytruda® (pembrolizumab) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy in adjuvant treatment after surgery for adults with locally advanced, or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence.
Biogen announced that it has withdrawn the MAA for aducanumab for the treatment of the early stages of Alzheimer’s disease, following feedback from the CHMP suggesting the data provided would not be sufficient to support a positive opinion.
Australia’s TGA granted orphan drug designation to Roche’s glofitamab. The TGA also provided approval for Roche to apply for registration using the provisional approval pathway, an expedited approval process. Roche has until 21 October 2022 to make an application through this pathway.
Amgen released preliminary results from its Ph III study of ABP654 (proposed ustekinumab biosimilar) in adults with severe plaque psoriasis. Amgen reported that the study met the primary efficacy endpoint, and that the safety profile of ABP654 was comparable to STELARA®.
Cancer Network reported that initial data from AstraZeneca’s Ph II trial of durvalumab and tremelimumab in combination with chemotherapy as neoadjuvant therapy for patients with advanced-stage ovarian cancer was presented at the AACR meeting. The results suggest that more than 80% of all patients had at least had a partial response to treatment, and five patients (11.11%) had a pathologic complete response.
Korea Biomedical Review reported that Celltrion released the results of its Ph III trials of CT-P16 (biosimilar bevacizumab candidate) at the American Association for Cancer Research 2022. Celltrion said that CT-P16 demonstrated equivalence in efficacy with Avastin®. Based on these results, Celltrion has completed an application for CT-P16 product approval in Korea, the U.S., and the EU seeking approval for a full label.
Amneal Pharmaceuticals announced that the FDA has approved its BLA for Alymsys® (biosimilar bevacizumab) marking the second of three oncology biosimilar approvals Amneal expects to receive in 2022. Alymsys® was developed by mAbxience, and its approval is the third biosimilar bevacizumab approved in the US.
Celltrion announced the launch of Yuflyma® (high-concentration, low-volume, citrate-free and latex-free biosimilar adalimumab) in Canada. Yuflyma® is approved in Canada for ten indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and paediatric uveitis.
Alvotech announced that it has resolved its patent disputes with AbbVie in Europe and selected markets elsewhere relating to Alvotech’s citrate free, high concentration adalimumab (AVT02, biosimilar to Humira®). This follows the resolution of the US litigation between AbbVie and Alvotech last month and paves the way for Stada to commercialise adalimumab in Europe under the Hukyndra® brand name. AbbVie has granted Alvotech a non-exclusive royalty bearing license to AbbVie’s Humira® patents in Europe and selected markets elsewhere.
Intas announced that it has signed an exclusive license and supply agreement with Axantia, a Middle Eastern pharmaceutical company, for the commercialisation of ranibizumab (biosimilar Lucentis®) in territories including Saudi Arabia, Jordan, Iraq and Lebanon.
31 March 22 | Fresenius Kabi announced that it has bought a majority stake (55%) in mAbxience, a company specialising in biosimilars, for an upfront EUR 495 million plus milestone payments, and Ivenix, which has a leading infusion therapy platform, for an upfront US$ 240 million plus milestone payments. These transactions are expected to close in mid-2022.
Telix Pharmaceuticals announced that the FDA has designated Telix’s monoclonal antibody TLX66 (90Y-besilesomab) an orphan drug for use in conditioning treatment of bone marrow prior to hematopoietic stem cell transplant.
Formycon and Athos KG announced that they have agreed to enter into a long-term strategic partnership regarding biosimilars. As part of this agreement, Formycon will acquire 100% of the rights in FYB202 (biosimilar ustekinumab candidate) and a 50% stake in FYB201 (biosimilar ranibizumab candidate) in exchange for EUR 650 million.
Lannett announced that it has commenced dosing in its pivotal trial of biosimilar insulin glargine.
Medical Xpress reports on an Institute of Cancer Research, London, study showing that levels of the protein PD-L1 detected in head and neck tumours can be used to personalise medicine. Depending on PD-L1 levels, patients should receive personalised medicine of either chemotherapy with or without cetuximab, pembrolizumab in combination with chemotherapy, or pembrolizumab alone.
Aurobindo announced that it will acquire certain business assets from Veritaz (the supplier of branded generic formulations and other health care products) for Rs 171 crore on a debt free basis. The acquisition will support Aurobindo’s plans to manufacture biosimilars and other products in India.
The Office of the Assistant Secretary for Preparedness and Response has announced that it will pause the distribution of sotrovimab in certain US states in which the BA.2 variant has become the dominant COVID-19 strain. This announcement follows FDA advice which indicates that sotrovimab is not effective against the BA.2 variant.
The FDA hosted a public meeting entitled ‘Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act’, in line with its previously stated commitment to do so no later than 30 September 2022.
The Government of British Columbia announced an expansion of its biosimilars switching program to include blood thinner enoxaparin. This change took effect on 22 March 2022, with all new PharmaCare approvals to be for biosimilar enoxaparin only.
Merck announced that the FDA has approved Keytruda® (pembrolizumab) (anti-PD-1 therapy) as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Keytruda® is also indicated in combination with Lenvima® (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR.
Henlius Biotech published the results of Ph II trials of novel anti-PD-1 monoclonal antibody serplulimab (novel anti-PD-1 mAb) in the treatment of advanced cervical cancer. Henlius reported that the study demonstrated a manageable safety profile and encouraging efficacy. Serplulimab is stated to be the first innovative mAb developed by Henlius.
Amgen and Pfizer settled their pegfilgrastim (Neulasta®) dispute Amgen Inc v Hospira Inc (D. Del., No. 20-201) which has been on foot since February 2020. No further details about the settlement agreement have been published to date.
Merck announced results from Ph III trials of Keytruda® (pembrolizumab) in patients with Stage IB-IIIA non-small cell lung cancer, reporting that Keytruda® significantly improved disease-free survival.
Prestige BioPharma published preclinical data on its first-in-class pancreatic cancer treatment PBP1510 (ulenistamab). PBP1510 is being developed as a potential treatment for pancreatic cancer and is currently in Ph 1/2a trials in France and Spain.
Merck announced that it will discontinue Ph III trials of Keytruda® (pembrolizumab) in combination with Lynparza® (olaparib) in patients with metastatic castration-resistant prostate cancer following the recommendation of an independent Data Monitoring Committee. Merck said that interim analysis indicated that the combination treatment did not demonstrate a benefit in overall survival.
The Centre for Biosimilars reported on a study on Celltrion’s CT-39 (biosimilar omalizumab) presented at the American Academy of Allergy Asthma and Immunology annual meeting. Celltrion reported that the study demonstrated equivalence with Xolair® (omalizumab).
Evio Pharmacy announced a roll-out of a biosimilar strategy to help make medicines affordable. Evio announced that it has contracted directly with biosimilars manufacturers for autoimmune disease and cancer therapeutics.
OcyonBio announced that it has entered into a manufacturing and operations agreement with Biosimilar Solutions Inc. to create a contract biosimilars development/manufacturing organisation (including process development, plasmid, vectors, cell banks, processing and testing facilities) in Puerto Rico. Biosimilar Solutions expects to manufacture recombinant proteins and monoclonal antibodies from 2022.
Samsung Bioepis and Biogen announced that Health Canada approved Byooviz™ (biosimilar ranibizumab) on 8 March for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization (CNV) secondary to pathologic myopia (PM) and choroidal neovascularization (CNV) secondary to ocular conditions other than AMD or PM. This is the first Health Canada approval of a biosimilar ranibizumab to date, and whilst is it Samsung’s 6th Canadian biosimilar, it is Biogen’s first. Byooviz™ was approved in the US in September 2021, and in the EU and the UK in August 21.
Alvotech announced that it has settled all pending US disputes with AbbVie, including the ITC case brought by AbbVie in December 2021. Under the settlement Alvotech will receive non-exclusive rights to market AVT02 (high-concentration, citrate-free biosimilar adalimumab) in the United States from 1 July 2023. This date is the same US license date AbbVie granted to Coherus and Boehringer Ingelheim in their respective settlements with AbbVie, which follows Amgen’s US license date of 31 Jan 23 and Samsung’s 30 June 2023. Alvotech is the only known company that has both developed a high-concentration biosimilar adalimumab and conducted switching studies to enable the launch of what is expected to be the first high concentration interchangeable biosimilar adalimumab in the US. Teva is Alvotech’s strategic partner for the US commercialisation of AVT02. AVT02 is already approved in Europe, Canada and the UK.
Merck published interim results from its Ph III trial of Keytruda® (pembrolizumab) as an adjuvant treatment for patients with stage IIB and IIC melanoma. According to the announcement, the trial met its key secondary endpoint and showed an improvement in recurrent-free survival compared to placebo.
Shanghai Henlius Biotech announced that China’s NMPA has approved its biosimilar rituximab (汉利康®)), as the first biosimilar approved in combination with methotrexate for the treatment of adult patients with rheumatoid arthritis who have inadequate response to one or more TNF-alpha antagonist therapies. Additional approved indications include NHL (mono therapy) and CLL in combination with fludarabine and cyclophosphamide.
The Juvenile Diabetes Research Foundation (JDRF) announced that it has entered into a partnership with not-for-profit generic manufacturing company Civica to manufacture biosimilar insulins, including biosimilars to glargine (Lantus®), lispro (Humalog®), and aspart (Novolog®). Biosimilar insulins are to be developed for the US market so that low-cost insulin is supplied irrespective of insurance status from 2024. JDRF is underwriting the initial development costs of the project, and Civica will manufacture and distribute biosimilar insulin for less than USD$30/vial, or $55/box of five pen cartridges.
FDA announced a new funding opportunity for the BsUFA III Regulatory Science Program to support research projects that “enhance biosimilar and interchangeable biological product development and regulatory science”.
Shanghai Junshi Biosciences announced that China’s NMPA has approved its biosimilar adalimumab product (50mg/ml) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis. The product was jointly developed by Shanghai Junshi Biosciences and Jiangsu T-mab BioPharma (T-mab Bio), a subsidiary of Mabwell (Shanghai) Bioscience Co (Mabwell Bio).
Celltrion launched Yuflyma® (high concentration citrate-free biosimilar adalimumab) in Korea.
AbbVie announced that is has completed its acquisition of Syndesi Therapeutics SA for $1B, including up front payment of $130M, with a further $870M in milestone payments. This acquisition will expand AbbVie’s neuroscience portfolio, giving AbbVie access to Syndesi’s portfolio, including lead molecule SDI-118, a small molecule which is currently in Ph Ib studies.
Amneal announced that the FDA has approved Amneal’s first biosimilar product Releuko™ (biosimilar filgrastim), a product developed by Kashiv Speciality Pharmaceuticals (which was acquired by Amneal in April 2021). Amneal also disclosed that US applications for biosimilar pegfilgrastim and bevacizumab are under FDA review, and Amneal plans to launch both products in 2022.
The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10th year anniversary. Six biosimilars have been approved globally: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab and ranibizumab. Eculizumab has recently completed its Ph III clinical trial, and three other biosimilar candidates are under Ph III trials.
Biocon announced that it will acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash to create a vertically integrated biosimilars leader. The transaction is expected to close in the second half of 2022, subject to conditions including certain regulatory approvals. The subject business revenues are expected to be USD1billion in 2023 alone.
Alvotech announced that the FDA has accepted the BLA including data supporting interchangeability for AVT02, Alvotech’s high-concentration (100mg/ml) biosimilar adalimumab. The Biosimilar User Fee Act goal date for FDA decision is December 2022.
Pfizer announced that the FDA has accepted its sBLA seeking interchangeability for Abrilada™ (biosimilar adalimumab). The Biosimilar User Fee Act goal date for FDA decision is Q4 2022.
Alvotech and Fuji Pharma announced that they have expanded their strategic partnership for Japan to include an undisclosed biosimilar currently in early phase development. This brings the total number of products covered by the partnership to six. Fuji will receive exclusive commercial rights to this biosimilar in Japan in exchange for upfront and milestone payments tied to development progression. Alvotech will also receive a share of the in-market sales.
Prestige BioPharma announced that the manufacturing facility for Tuznue® (biosimilar trastuzumab) has received EUGMP certification. Tuznue® is under Marketing Authorisation Application review in the EU, Canada and South Korea.
Janssen released data from a Ph 2a clinical trial of guselkumab and golimumab in ulcerative colitis. Janssen reported that the combination induced higher rates of clinical response, clinical remission, endoscopic improvement and a composite histologic-endoscopic endpoint at 12 weeks that either treatment alone.
Australia’s TGA provided a safety update for BMS’ Yervoy® (ipilimumab), resulting in a warning on the PI that ipilimumab has been linked to serous retinal detachment, a rare but serious adverse event.
Celltrion released two data sets on the subcutaneous (SC) form of Remsima® (biosimilar infliximab). Celltrion reported that switching from IV to SC infliximab leads to higher infliximab trough levels and a lower risk of relapse in patients with IBD.
Coherus BioSciences published its Q4 2021 financial results, reporting a net loss of $45.7 million. Coherus attributed this net loss to a decrease in the number of units of Udenyca® (biosimilar pegfilgrastim) sold, as well as a decline in net realised price due to increased competition and COVID-19 impacts.
The Korea Times reported that Celltrion’s net profit has grown 20% year-over-year. Celltrion has reported significant market shares in the US for its infliximab and rituximab biosimilars.
New Zealand’s Pharmac requested feedback on a proposal to provide access to Riximyo® (biosimilar rituximab) for patients with pemphigus. Riximyo® is not approved for pemphigus in New Zealand and would need to be prescribed by an authorised prescriber in accordance with section 25 of the Medicines Act. The consultation period closes on 1 March 2022.
The FDA awarded Medscape Education a contract for the development of an education curriculum and outreach program on the use of biosimilars in medical practice. The program will include accredited continuing education courses for physicians, pharmacists, and nurses.
The Korea Herald reported that Celltrion’s Remsima® (biosimilar infliximab) has captured 33.7% of the US market for infliximab since its approval in April 2016.
A real-world study of Pfizer’s Zirabev® (biosimilar bevacizumab) indicates that Zirabev® has been well adopted in US oncology practice.
Selexis SA and Generium JSC announced the launch of Genolar® (biosimilar omalizumab) in Russia.
Pfizer published its Q4 2021 financial results, reporting a 30% growth in biosimilars revenues year-over-year.
South Africa’s Competition Commission filed a referral with the Competition Tribunal for prosecution of Roche for alleged excessive pricing of trastuzumab.
Cardinal Health published its 2022 Biosimilars Report: The US Journey and Path Ahead. Cardinal predicted that 2022 is set to be a turning point for biosimilars in the US, reporting that most healthcare providers have a strong interest in using biosimilars to broaden patient access and drive more affordable care for their patients.
Biogen and Xbrane Biopharma announced that they have entered into a commercialisation and license agreement to develop, manufacture and commercialise Xcimzane™ (proposed biosimilar certolizumab pegol).
The International Generic and Biosimilar medicines Association (IGBA) announced that it has established a CEO Advisory Committee. Committee members represent Amneal Pharmaceuticals, Apotex, Cadila Healthcare, Cipla, Dr Reddy’s Laboratories, Insud Pharma, Lupin, Sandoz, STADA, Sun Pharmaceutical, Teva Pharmaceuticals, Towa Pharma and Viatris. IGBA announced that the Committee will provide a forum for industry leaders to discuss broad, strategic issues and to engage and position the industry on a range of critical issues.
Bloomberg reported that the potential sale of Novartis’ Sandoz division has drawn a lot of interest from private equity as well as from other generics manufacturers. Bloomberg reported that Blackstone Inc and Carlyle Group Inc are in talks to potentially team up on an offer, with other companies such as Advent International, Hellman & Friedman and KKR & Co said to be considering offers. Novartis announced the potential sale of its Sandoz division in its Q3 2021 financial results and a decision on the future of Sandoz is expected by the end of 2022.
Nova Scotia launched a biosimilars switching program. The program applies to certain insulins and products used for arthritis, IBD and psoriasis and pharmacare beneficiaries will have 12 months to apply the switch to biosimilars. Similar programs have already been introduced in British Columbia, Quebec, Alberta and New Brunswick.
Dr Reddy’s announced that it has entered into an agreement to acquire privately owned German medical cannabis company Nimbus Health GmbH. Dr Reddy’s said that the acquisition will allow it to introduce medical cannabis-based medicines as a promising treatment option for patients.
Australia’s National Medicines Policy Review Committee published a draft National Medicines Policy (NMP). The original NMP was established in 2000, with the stated aim of achieving both ‘optimal health outcomes and economic objectives’. The scope of the new NMP is proposed to be broadened to encompass biologic medicines, gene therapies, cell and tissue engineered products, and vaccines.
Samsung Bioepis announced that Health Canada has approved Ontruzant® (biosimilar trastuzumab) for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Alvotech announced that it has entered into an exclusive global licensing agreement with BiosanaPharma for the co-development of AVT23(BP001), a biosimilar omalizumab candidate.
Lupin announced that it has entered into a license, supply and technology sharing agreement with Axantia Holding for biosimilar pegfilgrastim in certain territories, including Saudi Arabia, Jordan, Lebanon, Iraq, Sudan, Libya and Algeria.
JAMP Pharma announced the creation of a new division BIOJAMP™ dedicated to biosimilars. The creation of this division was primarily made possible through JAMP’s exclusive agreement with Alvotech. Through the creation of the BIOJAMP™ division, JAMP Pharma plans to establish itself as a Canadian leader in biosimilars.
Genentech announced that the FDA has approved Vabysmo™ (faricimab) for the treatment of people with wet age-related macular degeneration and diabetic macular edema.
Biogen announced that Samsung Biologics will acquire Biogen’s equity stake in the Samsung Bioepis joint venture for an aggregate consideration of up to USD $2.3 billion.
MSD announced that the EC has approved Keytruda® (pembrolizumab) for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Vizient announced that remdesivir has replaced Humira® (adalimumab) as the most expensive drug by total member spend in its Winter 2022 Market Outlook. Pembrolizumab, ustekinumab, ocrelizumab, denosumab, infliximab, nivolumab and tocilizumab also featured in the top 10 most expensive drugs by member spend.
Bio-Thera Solutions announced that it has commenced Ph I studies regarding BAT6021 (a monoclonal antibody with enhanced ADCC targeting TIGIT in cancer cells).
Innovent and Eli Lilly announced the results of Phase Ib trials of Tyvyt® (sintilimab) plus biosimilar bevacizumab for advanced hepatocellular carcinoma. Innovent says that the safety profile is consistent with that observed in previously reported studies, without new or unexpected safety signals.
MSD and Eisai announced the publication of results from Ph III studies of Keytruda® (pembrolizumab) in patients with advanced endometrial carcinoma.
Biocon announced its Q3FY22 financial results, reporting a 28% year over year growth in biosimilars revenues.
Alvotech announced $21 million in additional commitments for private placement (PIPE) of Oaktree II common stock. Alvotech and Oaktree Acquisition Corp. II previously announced in December 2021 that they had entered into a pre IPO merger agreement. According to the announcement, the business combination is expected to deliver gross proceeds to Alvotech in excess of $475M.
The International Generics and Biosimilar Medicines Association (IGBA) announced the appointment of Vivian Fritelli as IGBA Chair for 2022.
Orion Corporation and CuraTeQ Biologics announced an expansion to their biosimilar distribution agreement in Europe to include the Baltic countries. All products under the agreement are still in development or regulatory phases, with launches estimated to take place in 2023-2026.
Alvotech and JAMP Pharma announced that Health Canada has approved Simlandi (high-concentration, citrate-free biosimilar adalimumab).
Coherus Biosciences announced that it has entered into a loan agreement with investment funds managed by Pharmakon Advisors, LP. The agreement will provide Coherus with up to $300 million committed across four tranches. The third and fourth tranches are conditional upon Coherus receiving approval of the BLA for its toripalimab and its biosimilar ranibizumab, respectively.
Amneal Pharmaceuticals and Saol Therapeutics announced that Amneal will acquire Saol’s Baclofen franchise. This acquisition is expected to bolster Amneal’s commercial infrastructure in advance of its planned launches of biosimilar filgrastim, biosimilar pegfilgrastim and biosimilar bevacizumab in 2022.
Samsung Bioepis and Organon announced that the FDA has accepted for review the supplemental Biologics License Application for a citrate-free, high-concentration formulation of SB5 (biosimilar adalimumab). Organon expects to launch this product in the US on or after 1 July 2023, in accordance with a licensing agreement with AbbVie.
Biocon Biologics announced that the US Court of Appeals for the Federal Circuit Court has upheld the US Patent and Trademark Appeal Board’s decisions of unpatentability for five device patents for Sanofi’s Lantus® (insulin glargine) SoloSTAR® as well as a district court decision on one of these patents. Biocon and Viatris launched Semglee® (interchangeable biosimilar insulin glargine) in November 2021.
Innovent Biologics announced that China’s NMPA has accepted the supplemental New Drug Application for sintilimab plus biosimilar bevacizumab injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer who progressed after EGFR-TKI therapy.
Health Canada approved Celltrion’s Yuflyma® (100mg/mL biosimilar adalimumab) for all indications as Humira®.
Theramex and Enzene Biosciences announced that they have entered into an agreement for the development and commercialisation of biosimilar tocilizumab. The product will be available in parenteral vials, PFS and autoinjectors from 2026 in Europe, the UK, Switzerland and Australia.
Sandoz announced that it has submitted a BLA to the EMA for a proposed biosimilar trastuzumab.
The FDA approved Eli Lilly’s Rezvlogar® (biosimilar insulin glargine).
Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab.
Hyphens Pharma announced that it has signed an exclusive license and supply agreement with DKSH’s subsidiary Favorex Pte Ltd for the commercialisation of Alvotech’s proposed biosimilar ustekinumab in Singapore, Malaysia and the Philippines.
Xbrane Biopharma announced it is developing two new biosimilar candidates referencing Keytruda® (pembrolizumab) and Darzalex® (daratumumab).
Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I study.
Novartis CEO Vas Narasimhan announced that the potential sale of Sandoz has attracted interest from potential buyers. Novartis is expected to decide the future of Sandoz by the end of 2022.
Dr Reddy’s and Prestige BioPharma announced that they have entered into an exclusive partnership for the supply and commercialisation of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia.
Hikma Pharmaceuticals and Gedeon Richter announced that they have entered into an exclusive license agreement to commercialise Gedeon Richter’s proposed denosumab biosimilar in the United States.
MoneyControl reported that Biocon and Mylan are in advanced talks for the creation of a biosimilars spin-off. To date neither party has confirmed this speculation.
Samsung Bioepis announced that its Ontruzant® (biosimilar trastuzumab) demonstrated comparable long-term survival results with reference trastuzumab in five-year follow-up results.
Prestige BioPharma announced that its Ph I study of PBP1502 (proposed adalimumab biosimilar) has been registered with the US National Institute of Health. Prestige disclosed that it plans to file marketing authorisation applications with the EMA and FDA in 2023.
Alvotech and Oaktree Acquisition Corp. II announced that they have entered into a merger agreement for the creation of a publicly-traded global biopharmaceutical company. Alvotech is led by a team of highly experienced biopharma leaders, including Mark Levick as CEO, Anil Okay as CCO, and Philip Caramanica as Chief IP Counsel and Deputy General Counsel. The merger is expected to deliver gross proceeds to Alvotech in excess of USD$450 million. Alvotech currently has seven products in its pipeline, including a biosimilar candidate to Humira® (adalimumab), Stelara® (ustekinumab), Eylea® (aflibercept), Prolia®/Xgeva® (denosumab) and Simponi®/Simponi ARIA® (golimumab).
Australia’s TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) for the treatment of adults with coronavirus who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.
Shanghai Henlius Biotech announced that China’s NMPA has approved Hanbeitai® (biosimilar bevacizumab) for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer.
Lupin and Biomm announced that they have entered into an exclusive distribution and marketing agreement for biosimilar pegfilgrastim in Brazil.
British Columbia announced that it has expanded its biosimilar program to include insulin. About 30,000 patients will now have six months to transition to Admelog® (biosimilar insulin lispro) and Trurapi® (biosimilar insulin aspart).
Tot Biopharm announced that China’s NMPA has approved Pusintin® (biosimilar bevacizumab) for the treatment of patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer and patients with metastatic colorectal cancer.
Mochida Pharmaceutical and Ayumi Pharmaceutical announced the launch of high-dose 100mg/mL Adalimumab BS MA (adalimumab biosimilar) in Japan.
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.
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 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 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.
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.
Pharmac announced that it will transfer Principal Supply status from Humira® (adalimumab) to Amgevita® (biosimilar adalimumab) from 01 March 2022.
Viatris and Biocon announced the US launch of Semglee® (interchangeable biosimilar insulin glargine) and Insulin Glargine.
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’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 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.
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 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.
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 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.
Pharmacy benefit manager Prime Therapeutics announced that it will add Semglee® (interchangeable biosimilar insulin glargine) to its preferred national formularies.
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 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.
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 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.
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 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 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.
Chugai Pharmaceutical announced that it will construct a new manufacturing facility in Tokyo to produce biopharmaceuticals for early clinical trials.
Biocon released its Q2 2022 financial results, reporting a 10% increase in biosimilars revenue year on year.
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.
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.
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.
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.
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.
MorphoSys announced that the first patient has been dosed in its Ph II trials evaluating felzartamab for patients with Immunoglobulin A Nephropathy.
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.
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).
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 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.
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.
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”.
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 announced the completion of two Ph III studies of its proposed insulin glargine biosimilar.
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.
The Korea Herald announced that Celltrion has submitted a Marketing Authorisation Application to the EMA for CT-P16 (proposed bevacizumab biosimilar).
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.
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.
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.
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.
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 entered into an agreement to manufacture Xcimzane™ (certolizumab pegol) for clinical development.
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 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.
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 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.
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.
Coherus Biosciences announced that the FDA has accepted for review the BLA for CHS-201 (proposed biosimilar ranibizumab).
Korea Biomedical Review reported that Celltrion has submitted an application for CT-P16 (proposed biosimilar bevacizumab) in the US and Korea.
Xbrane Pharma and STADA announced that the MAA for Xlucane™ (proposed biosimilar ranibizumab) has been submitted to the EMA.
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.
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.
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.
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.
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.
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 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.
Korea Biomedical Review reported that Samsung Bioepis and Genetech have signed a licence agreement for ranibizumab. Under the terms of the agreement, Samsung Bioepis can market its biosimilar ranibizumab from June 2022.
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.
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).
Syneos Health and CuraTeQ Biologics (a subsidiary of Aurobindo) are recruiting participants for a comparative trial to be conducted in New Zealand to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of omalizumab as subcutaneous injection in healthy male volunteers. The estimated study completion date is October 2022.
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.
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.
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 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).
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 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.
Alvotech announced that the EU’s CHMP has adopted a positive opinion recommending the approval of AVT02 (proposed adalimumab biosimilar).
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 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.
Australia’s TGA approved Kyowa Kirin’s Crysvita® (burosumab) for the treatment of X-linked hypophosphataemia.
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 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 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.
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.
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 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 announced that its biosimilar tocilizumab candidate MSB11456 successfully met its primary and secondary endpoints in Ph I trials of both subcutaneous and intravenous formulations.
Australia’s TGA approved Gilead Sciences’ Trodelvy® (sacitizumab) for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer.
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.
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 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).
China’s NMPA approved JW Therapeutics’ Relma-cel (relmacabtagene autoleucel) for the treatment of large B-cell lymphoma.
The UK’s NICE recommended Novartis’ Cosentyx® (secukinumab) as a treatment for plaque psoriasis in children aged 6-17 years.
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.
The UK’s NICE recommended UCB Pharma’s Bimzelx® (bimekizumab) as a treatment for plaque psoriasis in adults.
Australia’s TGA approved Celgene’s Reblozyl® (luspatercept) for the treatment of transfusion-dependent anaemia.
India’s DCGI granted marketing authorisation for Enzene Bioscience’s biosimilar denosumab.
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.
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.
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’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.
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 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.
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.
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.
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.
Novartis announced that China’s NMPA has expanded its approval of Cosentyx® (secukinumab) to include the treatment of plaque psoriasis in paediatric patients.
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.
The FDA announced the Biosimilar User Fee Act rates for the 2022 fiscal year. The new rates will apply from 01 October 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. Progenity disclosed that it has recently produced a GMP drug substance batch for its adalimumab oral biotherapeutics delivery system (PGN-0B1).
Brazil’s ANVISA granted emergency use authorisation (EUA) for Celltrion’s COVID‑19 treatment regdanvimab.
Celltrion announced that Herzuma® (biosimilar trastuzumab) gained 51% of the market share in Japan in June.
Enzene Biosciences announced that India’s DCGI has approved its biosimilar romiplostim for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults.
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 released its Q2 2021 financial results, reporting 8% growth in operational change for net sales of biosimilars and complex generics.
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.
Formycon and Bioeq announced that the BLA for FYB201 (proposed ranibizumab biosimilar) has been submitted to the FDA.
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.
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 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, reporting double digit volume growth for Prolia® (denosumab), Repatha® (evolocumab), Mvasi® (biosimilar bevacizumab) and Kanjinti® (biosimilar trastuzumab).
Celltrion announced it has won a tender to supply the Brazilian market with Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab).
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.
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.
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.
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 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 Therapeutics announced they have formed a new partnership to support biosimilar development and manufacturing.
Teva is recruiting participants for a US study to compare the safety and efficacy of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment. The estimated study completion date is May 2024.
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.
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 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 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.
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 announced that it has commenced Ph III trials of SB17 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.
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 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 announced that the first patient has been dosed in its Ph III trials of BAT206 (proposed ustekinumab biosimilar).
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.
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 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 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.
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.
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.
India’s Central Drugs Standard Control Organisation granted marketing authorisation for Lupin’s ranibizumab biosimilar.
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.
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 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 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 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 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.
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
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.
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.
UCB announced that the CHMP has recommended BIMZELX® (bimekizumab) for the treatment of plaque psoriasis.
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.
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.
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.
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 Biologics announced its Ph III trials of sintilimab in combination with chemotherapy met the overall survival primary endpoint.
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).
Taiwan-based Synermore Biologics is recruiting participants for a study to be conducted in Europe and Russia to compare SYN008 and Xolair for the treatment of chronic urticaria not well controlled by antihistamines.
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.
Amneal announced the FDA has accepted the BLA for Alymsys™ (proposed bevacizumab biosimilar). Alymsys™ was developed in collaboration with mAbxience.
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 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.
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Theramex enters agreement with Enzene Biosciences for biosimilar denosumab
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.
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.
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 announced it has initiated Ph III trials of BAT2506 (golimumab biosimilar).
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.
Celltrion launched Remsima SC® (subcutaneous infliximab biosimilar) in Canada. Remsima SC® is indicated for the treatment of rheumatoid arthritis.
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.
The UK’s NICE recommended Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis and psoriatic arthritis.
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 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 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.
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 announced its Ph I trials of DMB-3115 (proposed ustekinumab) biosimilar demonstrated the bioequivalence of its product to the reference product.
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.’.
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 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.
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.
Sandoz Canada launched Inclunox® (biosimilar enoxaparin sodium) in Canada.
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.
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 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.
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 filed a federal lawsuit against AbbVie in the US District Court of the Eastern District of Virginia, seeking to clear patent barriers relating to proposed 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 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.
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.
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.
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 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 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.
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 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 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 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.
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.
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.
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 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 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.
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 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.
Luye Pharma announced its marketing authorisation application for LY01008 (proposed bevacizumab biosimilar) has been accepted by China’s National Medical Products Administration.
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.
Prestige Biopharma and Pharmapark announced they have reached an agreement for the commercialisation of Prestige Biopharma’s proposed bevacizumab biosimilar in the Russian Federation.
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.
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.
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 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 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 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 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.
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.
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.
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.
PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the Brazilian market.
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.
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.
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.
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.
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.
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 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 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.
The Korea Herald reported that Celltrion’s Herzuma® (biosimilar trastuzumab) reached a 44% market share in Japan last year.
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®.
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.
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.
Korea Biomedical Review reported that Alteogen has completed Ph I trials of ALT-L9 (proposed aflibercept biosimilar).
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’.
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).
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 I trials for SB11 (proposed ustekinumab biosimilar).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Biocon and Viatris announces Kixelle® (biosimilar insulin aspart) has received marking authorisation approval in the EU.
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 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 announces it has commenced Ph III trials of its proposed aflibercept biosimilar.
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%.
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.
Enzene Biosciences announces it has received marketing authorisation for its biosimilar teriparatide in India.
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.
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.
The CHMP recommends13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience’s Alymsys® and STADA’s Oyavas®.
Bio-Thera Solutions announces the FDA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).
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.
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 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 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 announces it has submitted an investigational new drug application for Ph III trials of CT-P41 (proposed denosumab biosimilar).
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.
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.
Innovent announced China’s NMPA has approved Byvasda® (biosimilar bevacizumab) for the additional indication of adult recurrent glioblastoma.
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.
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 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.
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 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.
FDA approves Riabni®
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.
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 Bioepis announces it has commenced Ph III trials of SB16 (proposed denosumab biosimilar) in women with postmenopausal osteoporosis.
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).
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.
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.
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.
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.
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.
Shanghai Henlius Biotech announces its adalimumab biosimilar HLX03 has been approved by China’s NMPA for rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.
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 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.
Bio-Thera Solutions announced it has submitted a marketing authorisation application for BAT1706 (proposed bevacizumab biosimilar) in EU.
Janssen announced that the European Commission has approved Tremfya® (guselkumab) for the treatment of adult patients with active psoriatic arthritis.
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.
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.
BGP Pharma receives a NOC from Health Canada for Hulio® (biosimilar adalimumab).
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 positive results from Ph III trials of its biosimilar bevacizumab candidate.
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.
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.
Samsung Bioepis and Biogen announce the FDA has accepted for review the BLA for SB11 (proposed ranibizumab biosimilar).
The EMA approved Pfizer’s Nyvepria® (biosimilar pegfilgrastim).
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.
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.
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 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 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 announces it has commenced Ph I trials for SB16 (proposed denosumab biosimilar).
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 announces it has commenced Ph I trials for HLX14 (proposed denosumab biosimilar).
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 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.
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.
The Australian Government announced it has secured an additional 50 million potential COVID-19 vaccine doses through agreements with Novavax and Pfizer/BioNTech.
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.
Amgen receives three Notices of Compliance (NOC) from Health Canada relating to Amgevita® (50mg/mL biosimilar adalimumab).
Hindu Business Line reported Strides Pharma has filed a submission with the EMA for PTH® (proposed teriparatide biosimilar).
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 the results of Ph III studies of CT-P17 (proposed adalimumab biosimilar) demonstrate comparable efficacy and safety against reference adalimumab in rheumatoid arthritis.
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.
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.
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.
Fresenius Kabi receives a Notice of Compliance relating to its biosimilar adalimumab (50mg/mL), Idacio®.
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.
In its Q3 2020 financial results, Amgen announces that it is moving ABP 654 (proposed ustekinumab biosimilar) into Ph III development.
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.
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 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.
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 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commence recruiting in Poland.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
Korea Biomedical Review reports Celltrion has received approval for Ph III trials of CT-P39 (proposed omalizumab biosimilar).
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.
Samsung Bioepis and Biogen announce the European Medicines Agency has accepted for review its Marketing Authorisation Application for SB11 (proposed ranibizumab biosimilar).
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.
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.
Lupin receives approval for biosimilar etanercept in Australia under the trade names Etera® and Rymti® in PFS presentations.
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.
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 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.
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.
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.
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
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.
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 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 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
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.
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
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.
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.
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 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.
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 dosing in Ph I clinical trials of BAT2206 (proposed ustekinumab biosimilar).
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 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.
Innovent Biologics announces China’s NMPA has approved Sulinno® for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.
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 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.
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 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 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.
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.
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).
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 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.
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.
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Bio-Thera Solutions and BeiGene announce executed agreement
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.
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.
Pfizer’s application to PBS list its biosimilar bevacizumab (Zirabev®) under the same conditions as Avastin® was recommended.
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 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.
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.
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.
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.
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.
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.
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.
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.
Korea Biomedical Review reports that Celltrion will commence Ph I clinical trials of CT-P41 (biosimilar denosumab candidate) in September.
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.
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.
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 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.
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.
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.
Celltrion releases its Q2 FY20 earnings report. Celltrion reported that Remsima SC® remains in Ph III clinical trials in the US.
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.
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 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.
Janssen announces the FDA approved an additional indication for Stelara® (ustekinumab) for paediatric patients with skin lesions or moderate to severe plaque psoriasis.
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.
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 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.
Pfizer releases its Q2 FY20 financial results. Pfizer reveals that it plans to launch Nyvepria® (biosimilar pegfilgrastim) in the US later this year.
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.
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®.
A new study published by the Journal of Clinical Pathways demonstrates significant cost-savings generated by Sandoz’s pegfilgrastim biosimilar Ziextenzo®.
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.
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 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 releases its Q2 FY20 financial results, reporting COVID-19 negatively impacted demand for Lucentis® (ranibizumab).
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.
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.
VentureTECH, Duopharma and PanGen Biotech announce a joint venture to develop a Malaysian biosimilar production facility.
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.
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.
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.
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.
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.
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 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.
FDA approves Hulio®
Mylan announces FDA approval of Hulio® (biosimilar adalimumab) for PFS and auto-injector presentations.
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.
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 announces it has completed patient enrolment for its NORSE 2 clinical trials of Lytenava® (proposed bevacizumab biosimilar).
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.
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.
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.
Amgen receives Australian approval for Mvasi® (biosimilar bevacizumab) for all indications as Avastin®.
Samsung Bioepis announces it has commenced Ph III trials of SB15, proposed aflibercept biosimilar.
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.
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.
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.
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.
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 announces it has discontinued its Ph III LOTUS study of Stelara® (ustekinumab) in Systematic Lupus Erythematosus due to lack of efficacy.
Samsung Bioepis announces the CHMP has adopted a positive opinion for Aybintio® (biosimilar bevacizumab).
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.
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 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.
Bio-Thera Solutions announces China’s NMPA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).
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.
TGA approves Idacio®
Fresenius Kabi receives Australian approval for Idacio® (biosimilar adalimumab) with identical indications as Humira®, in 40mg vial, PFS and pen.
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 it has received approval to commence a global Ph III trial of SB15 (proposed aflibercept biosimilar) in patients with age-related macular degeneration.
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.
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Celltrion enters deal to acquire Takeda Pharmaceuticals Primary Care businesses
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.
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.
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.
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.
Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).
Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).
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.
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.
Mylan and Lupin announce EMA marketing authorisation for Nepexto® (etanercept) for all indications of the reference product Enbrel®.
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.
Eli Lilly announced that the FDA has approved Taltz® (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis.
Henlius Biotech announces it has received a positive CHMP opinion, recommending marketing authorisation for HLX02 (proposed trastuzumab biosimilar).
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.
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.
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.
Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.
Shanghai Henlius Biotech announces that China’s National Medical Products Administration has approved its IND application for HLX14, a proposed denosumab biosimilar.
Fresenius Kabi announces that the FDA has accepted its BLA for MSB 11455, a proposed pegfilgrastim biosimilar.
Shanghai Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 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.
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 announces that the first group of subjects in the Australian randomised Ph I trials of JHL1266 (proposed denosumab) have been dosed.
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 releases an update on its biosimilar portfolio. Ph III clinical trials for a proposed ustekinumab biosimilar are scheduled to commence in Q3 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.
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 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 receives good manufacturing practice compliance certificate from the EMA for Bengaluru facilities.
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.
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 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 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 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.
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 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.
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 the University of Oxford announced an agreement for the global development and distribution of a potential recombinant adenovirus vaccine.
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.
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.
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.
Henlius Biotech announces it has received two EU GMP certificates related to its trastuzumab biosimilar HLX02.
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.
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 it has completed monitoring visits and blood sampling for Ph I trials of NeuLara.
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.
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 announces it is continuing clinical trials of its ranibizumab candidate and remained on-track for target dates for regulatory filings despite CoVid-19.
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.
Eli Lilly announced that the FDA has approved Taltz® (ixekizumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis.
Biocad announces it has received registration certificates from Bosnia and Herzegovina for Acellbia® (rituximab) and Herticad® (trastuzumab), with a launch expected in 2020.
BiosanaPharma releases the results of Ph I trials of BP001 (omalizumab), reporting comparability to Xolair®.
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.
Mylan and Lupin announce the EU’s CHMP has adopted a positive opinion recommending Nepexto® (etanercept) for all indications as Enbrel®.
Janssen announces approval of additional indication of ulcerative colitis for Stelara® (ustekinumab) in Japan.
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 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.
Samsung Bioepis announces the FDA has approved its 420mg multi-dose vial of Ontruzant® (trastuzumab).
A new study reports that Truxima® is comparable to the originator in terms of efficacy and safety in the treatment of multiple sclerosis.
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.
J&J announces Dano® is now also indicated for the treatment of adults with moderate to severe Crohn’s Disease.
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.
Celltrion submits its application for CT-P17 (adalimumab) to the EMA. If approved, CT-P17 will be the first high-concentration adalimumab available.
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.
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.
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.
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.
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 (bevacizumab candidate) met the primary endpoint in Ph III clinical trials.
Pfizer announces positive CHMP opinion for Ruxience® .
Health Canada approves ulcerative colitis as an additional indication for Stelara®.
Pfizer launches Ruxience® in the US at a 24% discount to Rituxan®.
Pfizer announces biosimilar TmAb Trazimera® will launch in the US on 15 February at a 22% discount to Herceptin.
The UK’s NICE announces it will not recommend Stelara® for moderately to severely active ulcerative colitis due to uncertainties over cost-effectiveness.
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.
We previously reported that Fresenius Kabi surrendered its patent AU2015263246 in the patent office in November 2019, which was the subject of a revocation suit commenced by Samsung Bioepis in July 2019. The Court entered orders today dismissing the proceeding by consent, and ordering Fresenius to pay Samsung’s costs.
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.
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.
Alvotech and JAMP announce agreement to commercialise five biosimilar products in Canada.
Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung’s adalimumab candidate in Taiwan and Hong Kong.
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.
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 announces it has commenced dosing in Ph III trials of etanercept.
Bio-Thera launches adalimumab biosimilar, Qletli® in China following Nov 2019 approval.
Samsung and AffaMed announce Chinese approval for Phase III trials of eculizumab candidate.
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.
Pfizer launches bevacizumab biosimilar Zirabev® in the US, at a 23% discount to Avastin®.
Sorrento Therapeutics announces partner Mabpharm has submitted a New Drug Application for its biosimilar infliximab to the Chinese NMPA.
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 announces it has received approved to enter clinical trials in China with SCB-808, biosimilar etanercept.
Amgen submits BLA for biosimilar rituximab to FDA.
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 ustekinumab biosimilar.
Qilu receives Chinese approval for its bevacizumab biosimilar, Ankada®.
Dong-A Socio Holdings and Meiji Seika announce commencement of Ph I trials of ustekinumab biosimilar.
Lupin releases results of Ph III trials of etanercept biosimilar, reporting similarity with the reference product.
Pfizer receives positive CHMP opinion for its biosimilar adalimumab product.
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.
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.
AffaMed receives Chinese approval to commence Ph III trials of Samsung’s trastuzumab biosimilar SB3.
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.
Amgen announced that the FDA has approved Avsola® (infliximab) for all Remicade® approved indications.
NeuClone announces results of Ph I trials of trastuzumab biosimilar, reporting the product successfully met primary and secondary endpoints.
Bio-Thera announces NMPA approval to commence Ph I trials of ustekinumab biosimilar.
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.
Mylan and Biocon announce the launch of Ogivri® in the US.
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.
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.
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 announces proposed trastuzumab biosimilar met primary endpoint in Phase III clinical trials.
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.
Pfizer receives Australian approval for bevacizumab biosimilar, Zirabev®.
FDA accepts BLA for proposed bevacizumab biosimilar.
Polpharma commences dosing in Phase III trials of proposed natalizumab biosimilar.
Sandoz launches pegfilgrastim product, Ziextenzo®, in the US, at a 37% discount to the reference product, Neulasta®.
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, including interim results of the COMPACT study, and long-term cost savings modelling analysis.
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 announce launch of Truxima® in the US, at a 10% price reduction compared to Rituxan®.
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 wins ‘Biosimilar Initiative of the Year’ for its biosimilar rituximab at the Global Generics and Biosimilars Awards.
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 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.
FDA approves Sandoz’s pegfilgrastim biosimilar Ziextenzo®.
Gene Techno Science and Kishi Kasei announce agreement for the joint development of an aflibercept biosimilar.
Pfizer releases positive interim analysis of data from clinical trials of Pfizer’s Inflectra®.
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 announces dosing has begun in PhI clinical trials of ustekinumab biosimilar.