Significant biosimilar activities this week include:
09 Feb 23 | EU | EMA accepts MAA for Alvotech’s AVT04 (ustekinumab biosimilar)
Alvotech and STADA announced that EMA has accepted the MAA for Alvotech’s AVT04 biosimilar to Janssen’s Stelara™. The companies expect the EMA to recommend AVT04 for approval as early as the second half of 2023. In January 2023, the FDA accepted for review the BLA for AVT04.
08 Feb 23 | US | FDA approves Eylea® (aflibercept) for retinopathy of prematurity
Regeneron announced that the FDA has approved Eylea® (aflibercept) for the treatment of preterm infants with retinopathy of prematurity. Eylea is now approved in the US to treat five retinal conditions caused by ocular angiogenesis.
06 Feb 23 | Alvotech exclusive agreement with Advanz Pharma regarding omalizumab for EU, UK, CA, CH and ANZ
Alvotech announced that it has entered into an exclusive agreement with Advanz Pharma for the commercialisation of AVT23 (omalizumab, biosimilar to Novartis’ Xolair™). The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand. Alvotech will be responsible for development and manufacture, while Advanz Pharma will handle registration and commercialisation of AVT23.
6 February 2023 | US | FDA accepts Sandoz’s Prolia® (denosumab) and Xgeva® (denosumab) biosimilar BLAs
Sandoz reported on 6 February 2023 that the US Food and Drug Administration (FDA) accepted its Biologics License Applications (BLAs) for its proposed biosimilar denosumab products. Sandoz reported that the application includes all indications covered by Amgen’s Prolia® and Xgeva®, including osteoporosis, treatment-induced bone loss, prevention of skeletal related complications in cancer, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy. Denosumab is a human monoclonal antibody which binds and inhibits RANKL, a protein essential for the function of osteoclasts (cells responsible for bone resorption). This binding inhibits osteoclast function, decreasing bone resorption.
Sandoz is “proud to be among the first to submit a BLA for a denosumab biosimilar”. We previously reported that the FDA was investigating the risk of Prolia® in advanced kidney disease, and Alovtech commenced a confirmatory patient study for their denosumab biosimilar in August 2022.
03 Feb 23 | Merck publishes new data on Keytruda® (pembrolizumab)
Merck announced that Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy met its primary endpoint of progression-free survival for the treatment of stage III-IV or recurrent endometrial carcinoma. Reportedly, the safety profile of Keytruda was consistent with that observed previously, with no new safety signals identified.
31 Jan 23 | US | First biosimilar adalimumab launched in the US by Amgen
The much anticipated launch of the first US Humira biosimilar occurred with Amgen launching Amjevita® (adalimumab) on 31 January 2023, pursuant to its settlement agreement with AbbVie which was penned in September 2017. Amjevita® is the first adalimumab biosimilar to be launched in the US and is available at a Wholesale Acquisition Cost 55% below the current Humira® list price. Biosimilars developed by Alvotech, Celltrion, Mylan/Viatris, Sandoz, Momenta, Pfizer, Fresenius Kabi, Samsung Bioepis/Merck, Coherus and Boehringer Ingelheim are able launch in the US later this year, in accordance with their settlements with AbbVie.
On 16 September 2022 Pearce IP prepared a Vlog in its PiPCast® series on IP strategies to enable the launch of biosimilars around the world, with a particular focus on Australia.
30 Jan 23 | EU | Sandoz receives positive opinion for citrate-free high concentration Hyrimoz® (adalimumab)
The CHMP adopted a positive opinion recommending the approval of a citrate-free high concentration formulation of Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira®. The positive opinion relates to all indications in the reference product, Humira®. Hyrimoz was first approved in the EU in July 2018, and Sandoz is seeking to expand its approved indications to those of Humira.
30 Jan 23 | EU | EC approves Sanofi’s Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis
The EC approved Sanofi’s Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE). Dupixent is the first medicine specifically indicated to treat EoE in Europe and the US.
27 Jan 23 | Celltrion launches Vegzelma™ (biosimilar bevacizumab) in Japan
Korea IT Times reported that Celltrion Healthcare has launched Vegzelma™, bevacizumab, biosimilar to Roche’s Avastin™, in Japan. Vegzelma received approval in Japan in September 2022.
27 Jan 23 | AU | PBAC recommends amending PBS listing of Actemra® (tocilizumab)
Australia’s PBAC recommended amending the circumstances under which Roche’s Actemra® (tocilizumab) is available for reimbursement via the PBS. The new PBS listing of Actemra includes ultrasound in the clinical criteria as a method for diagnosis of giant cell arteritis.
17 Jan 23 | US | Celltrion files IPR petition against Regeneron aflibercept patent
Celltrion filed a petition for inter partes review of Regeneron’s US 10,464,992, relating to Eylea® (aflibercept). Celltrion has alleged the 992 patent is invalid on obviousness and anticipation grounds. In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the 992 patent.
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