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Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers,” finalizing a previously issued draft guidance of the same title issued on July 23, 2024.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…
On September 30, 2026, the U.S. District Court for the District of Delaware issued an order granting Janssen Biotech, Inc. and Janssen Sciences Ireland UC’s (collectively, “Janssen”) motion for a preliminary injunction in Janssen Biotech, Inc. v. Accord BioPharma, Inc., No. 1:26-cv-00222 (D. Del.). The order enjoins defendants Accord BioPharma,…
STADA and Sino Biopharmaceutical Limited (“SBP Group”), through its subsidiary Chia Tai Tianqing Pharmaceutical Group (“CTTQ”), have entered into a partnership to manufacture, market, and sell biosimilars. CTTQ will develop, manufacture, and supply biosimilar candidates, while STADA will hold the marketing authorizations and have exclusive sales and marketing rights in…
On September 9, 2026, the U.S. Patent and Trademark Office issued a Notice of Decisions on Institution granting institution in four inter partes review proceedings challenging Janssen Biotech, Inc.’s golimumab method-of-treatment patents: IPR2026-00256, IPR2026-00257, IPR2026-00258, and IPR2026-00259. The notice states, “after review of the merits, the petitioner has shown a…
On September 17, 2026, Dualitas Therapeutics, Inc. (“Dualitas”) announced a research collaboration and license agreement with Roche to advance novel bispecific antibodies (“BsAbs”) for immunology and inflammation diseases, using Dualitas’ DualScreen Bispecific Discovery Engine. Under the collaboration, Dualitas will functionally screen over 300,000 novel bispecific combinations to discover and develop…