Topic
Biosimilars
850 published works
Big Molecule Watch
Alvotech and Advanz Pharma Announce Submission for Proposed Eylea 8 mg Biosimilar
By Alice Yoon
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…
Big Molecule Watch
FDA Accepts Formycon and Zydus’ Proposed Pembrolizumab Biosimilar for Review
By Alice Yoon
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…
Big Molecule Watch
Genentech and Biocon Settle Pertuzumab Biosimilar BPCIA Litigation
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…
Big Molecule Watch
Teva and Samsung Bioepis Add Up to Six Biosimilar Candidates to Partnership
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…
Big Molecule Watch
FDA Finalizes Q&A Guidance on Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products
By Sam Herron
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…
Big Molecule Watch
Fresenius Acquires Remaining 45% Stake in mAbxience for Up to €750 Million
By Sarah Adam
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.…
Big Molecule Watch
Celltrion Launches Omalizumab Biosimilar in the United States
By Wendy Leben
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…
Big Molecule Watch
Sandoz and mABxience Announce Collaboration for Proposed Emicizumab Biosimilar
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…
Big Molecule Watch
Biocon’s Pertuzumab Biosimilar Receives Positive CHMP Opinion Under EMA’s Tailored Clinical Approach
By Yoko Bian
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…
Big Molecule Watch
Janssen Granted Preliminary Injunction Against Golimumab Biosimilar
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…