Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab. According to the press release, RANIVISIO (ranibizumab) will be the first…
Regeneron filed a complaint yesterday against Mylan in the U.S. District Court for the Northern District of West Virginia, alleging infringement of twenty-four patents under the BPCIA based on Mylan’s submission of an aBLA for M710, a proposed biosimilar of EYLEA (aflibercept). Regeneron asserts that use of Mylan’s M710 infringes seven…
On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab). The BLA includes both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. This is the first BLA accepted by FDA for a tocilizumab biosimilar. …
Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to Biogen’s TYSABRI®. The proposed natalizumab biosimilar is for treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). The application is for an intravenous…
On Monday, Hikma announced a partnership with Celltrion to market YUFLYMA (CT-P17) in the Middle East and North Africa. CT-P17 is a high-concentration, low-volume and citrate-free adalimumab biosimilar, indicated for the treatment of a number of conditions including rheumatoid arthritis, ankylosing spondylitis, and Crohn’s disease. According to Hikma, CT-P17 provides…
Last week Alvotech announced that it has initiated a confirmatory study for its biosimilar candidate to EYLEA®, AVT06 (aflibercept). EYLEA® is indicated for treating a variety of eye disorders including wet AMD, macular edema, and diabetic retinopathy. According to Alvotech, the study “is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence…
The ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics will be held on June 28 – 29, to contemplate the details of the rapidly changing landscape for biosimilars and innovator biologics. Goodwin is a proud sponsor of the conference and, Goodwin partner and Big Molecule Watch editor, Huiya Wu is a…
Organon announced yesterday that it has entered into an agreement with Henlius, whereby Organon will license commercialization rights for biosimilar candidates referencing PERJETA® (pertuzumab) and PROLIA®/XGEVA® (denosumab). According to the press release, Henlius independently developed both biosimilar products. Organon will acquire exclusive global commercialization rights except for China. The agreement…
On May 19, 2022, Viatris Inc. and Biocon Biologics Ltd. announced that ABEVMY, a bevacizumab biosimilar, is now available in Canada. According to the press release, Viatris and Biocon Biologics co-developed ABEVMY, which references Roche’s AVASTIN (bevacizumab), a recombinant humanized monoclonal antibody that selectively binds to human vascular endothelial growth…
Amgen recently announced preliminary results from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA (ustekinumab) in adult patients with moderate to severe plaque psoriasis. According to Amgen, the “study met the primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and…