On October 13, 2026, the European Union’s (EU) European Commission made Sanofi’s commitments not to disparage a competing flu vaccine legally binding.
The Commission found that Sanofi’s enhanced flu vaccine in the EU, Efluelda, competes with the EU’s only
Big Molecule Watch
Big Molecule Watch, published by Goodwin Procter, focuses on legal developments related to biologic drugs, biosimilars, and complex pharmaceutical products. The blog covers regulatory approvals, patent litigation, and market entry strategies for biosimilars and innovative biologic therapies. It reports on FDA and European Medicines Agency decisions, patent settlements, and industry trends affecting the life sciences sector. Topics include biosimilar launches, regulatory compliance, intellectual property disputes under the Biologics Price Competition and Innovation Act (BPCIA), and advancements in cell and gene therapies. The blog serves as a resource for legal professionals and industry stakeholders tracking the evolving landscape of biologic medicines.
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Alvotech and Advanz Pharma Announce Submission for Proposed Eylea 8 mg Biosimilar
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…
FDA Accepts Formycon and Zydus’ Proposed Pembrolizumab Biosimilar for Review
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…
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 against Biocon Biologics Inc. concerning its proposed pertuzumab biosimilar.…
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 biosimilar candidates. As with the companies’ previous collaborations, Samsung Bioepis…
FDA Finalizes Q&A Guidance on Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products
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…
Fresenius Acquires Remaining 45% Stake in mAbxience for Up to €750 Million
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…
Sanofi and Regeneron Expand Immunology Collaboration in Deal Worth Up to $8 Billion
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…
Celltrion Launches Omalizumab Biosimilar in the United States
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…
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 hemophilia A.
According to Sandoz, the collaboration would add its…