On October 14, 2026, Alvotech and Advanz Pharma announced the submission of a European regulatory application for AVT29, a proposed biosimilar to Eylea® 8 mg (aflibercept 114.3 mg/mL), marketed as Eylea HD® in the United States. This is the first publicly announced regulatory submission worldwide for a proposed biosimilar to…
On October 13, 2026, Formycon and Zydus announced that the FDA accepted for review the Biologics License Application for FYB206, a proposed biosimilar to Merck’s KEYTRUDA® (pembrolizumab). This is the first publicly announced FDA acceptance of an application for a proposed KEYTRUDA® biosimilar. Formycon also submitted the regulatory dossier to…
On October 14, 2026, the U.S. District Court for the District of New Jersey entered an order dismissing without prejudice all claims in Genentech Inc. and Hoffmann-La Roche Inc.’s BPCIA litigation against Biocon Biologics Inc. concerning its proposed pertuzumab biosimilar. The same day, Biocon announced that it had entered into a…
On October 1, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) and Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced a new global license, development, and commercialization agreement for up to six potential biosimilar candidates. As with the companies’ previous collaborations, Samsung Bioepis will be responsible for development, regulatory registration, and manufacturing, while…
On October 13, 2026, the FDA announced the availability of a final guidance for industry entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers,” finalizing a previously issued draft guidance of the same title issued on July 23, 2024. The FDA issued the guidance pursuant to…
On October 1, 2026, Fresenius SE & Co. KGaA (“Fresenius”) announced that it acquired the remaining 45% of mAbxience Holding S.L. (“mAbxience”) from Insud Pharma S.L. and Invim Corporativo, S.L. for up to €750 million, including a contingent payment of €50 million upon certain site approvals. The transaction was completed…
On October 1, 2026, Sanofi and Regeneron Pharmaceuticals, Inc. (“Regeneron”) announced an expansion of their existing immunology collaboration to develop and commercialize four long-acting antibodies. Sanofi will pay Regeneron $1 billion upfront, with up to an additional $7 billion in development, regulatory, and commercial milestone payments. The four antibodies…
On October 5, 2026, Celltrion USA announced that OMLYCLO® (omalizumab-igec) is commercially available in the United States. OMLYCLO® is the first and only FDA-approved interchangeable biosimilar to Genentech and Novartis’s XOLAIR® (omalizumab). As we previously reported, the FDA approved the anti-IgE antibody in March 2025 for all four XOLAIR® indications: moderate…
On September 18, 2026, Sandoz announced a licensing, development, manufacturing, and commercialization agreement with mAbxience for a proposed biosimilar to Genentech’s HEMLIBRA® (emicizumab). HEMLIBRA® is approved for the treatment of hemophilia A. According to Sandoz, the collaboration would add its first hemophilia biosimilar to the company’s pipeline. Under the agreement,…
On September 22, 2026, Biocon Biologics Limited (“Biocon”) announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending marketing authorization for PEBRILZO® (pertuzumab), its biosimilar to Genentech’s PERJETA®. According to Biocon, PEBRILZO® is the first monoclonal antibody biosimilar to receive…