On June 5, Lupin announced that the U.S. Food and Drug Administration (“FDA”) approved RANLUSPEC, a ranibizumab biosimilar to Genentech’s LUCENTIS®. RANLUSPEC, which received European Marketing Authorization earlier this year, is indicated for the treatment of neovascular (wet) age-related macular degeneration and other retinal vascular disorders. It is the only…
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for two ranibizumab biosimilars, VISLYFA and REXATILUX, recommending granting of a marketing authorization. Ranibizumab is a VEGF-A inhibitor, and can be used to treat macular degeneration via an intravitreal injection; the reference product, LUCENTIS, was…
On February 13, 2026, STADA and Bio-Thera announced that they have received European Marketing Authorization for GOTENFIA®, a golimumab biosimilar to Johnson & Johnson’s SIMPONI®. GOTENFIA® is a human monoclonal antibody that targets tumor necrosis factor-alpha (TNF-α), a key driver of inflammation in multiple autoimmune conditions. GOTENFIA® has been approved in…
Just in December, six companies have announced the launch of their denosumab biosimilars in Europe: Sandoz, Samsung Bioepis, Fresenius Kabi, Zentiva, Biocon Biologics, and Accord. On December 1, 2025: Sandoz launched its denosumab biosimilars, WYOST (120 mg) and JUBBONTI (60 mg) in Europe. WYOST is approved for the treatment of…
As we have previously reported, on June 21, 2023, the FDA accepted Xbrane’s sBLA for LUCAMZI, a proposed ranibizumab biosimilar to Genentech’s LUCENTIS (ranibizumab). On October 16, 2025, Xbrane Biopharma AB announced that it has entered into a financing solution with Fenja Capital II A/S (Fenja) to proactively secure the…
On August 12, 2025, Lupin Limited (“Lupin”) announced that it has partnered with Sandoz Group AG (“Sandoz”) to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions. Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). Its indications encompass…
On July 17, 2025, Harrow, Inc. (“Harrow”), announced an agreement with Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) to acquire the U.S. commercial rights to two of Samsung Bioepis’s biosimilars, BYOOVIZ® (ranibizumab-nuna) and OPUVIZ™ (aflibercept-yszy). Harrow is a North American pharmaceutical company that specializes in ophthalmologic products including topical antibiotic/corticosteroid combinations,…
On January 10, 2025, Teva Pharmaceutical Industries Ltd. and Samsung Bioepis Co., Ltd. announced that they entered into a licensing agreement to commercialize EPYSQLI® (eculizumab-aagh), Samsung’s biosimilar of Soliris®, in the United States. According to the agreement, Samsung Bioepis will handle the development, regulatory registration, manufacturing, and supply of the…
The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024. Notably, the committee adopted positive opinions for the following 6 biosimilar products: Samsung Bioepis’s EKSUNBI (ustekinumab), Formycon AG’s FYMSKINA (ustekinumab), and Fresenius…
On January 22, 2024, Sandoz announced its plans to acquire the U.S. biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. (“Coherus”) for an upfront cash purchase payment of USD 170 million. The acquisition includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access…