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
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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
SEC Staff Provides Equity Compensation Relief and Clarifies Insider Reporting Deadlines
On October 15, 2026, the SEC’s Division of Corporation Finance issued new and revised Corporation Finance Interpretations (CFIs) providing additional flexibility for registering compensatory awards, including awards assumed in acquisitions and granted before an IPO. The guidance also clarifies registration
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Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers,” finalizing a previously issued draft guidance of the same title issued on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
SEC Issues Section 21(a) Report on Investor Coalitions, “Group” Formation, and Schedule 13G Eligibility
On October 7, the SEC issued a report of investigation under Section 21(a) of the Exchange Act addressing whether members of Climate Action 100+ (CA100) violated the beneficial ownership reporting provisions of the Exchange Act in connection with the election
Tokenized Trading Is Coming to Public Equities: Are You Prepared for the 30-Day Opt-Out Deadline?
Tokenized securities are moving from what was once theory to regulated market infrastructure. For the first time, pursuant to an SEC exemptive order, third parties may be able to tokenize and facilitate trading of your company’s stock unless you affirmatively