On March 26, 2026, the U.S. Food and Drug Administration approved Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel), the first gene therapy treatment for pediatric patients with severe Leukocyte Adhesion Deficiency Type I (LAD-I). LAD-I is an inherited immune deficiency cause by mutations in the ITGB2 gene that leaves patients susceptible to…
On April 2, 2026, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved an extension to the dosing intervals for EYLEA HD (aflibercept) patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The approval increases the maximum dosing interval from 16 weeks to 20…
This past year contained a number of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top three legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Start to Resolve As in 2023 and 2024, Regeneron’s multi-district…
On November 17, 2025 Formycon AG (“Formycon”) announced development of a dupilumab biosimilar, FYB208, referencing Regeneron and Sanofi’s DUPIXENT. Dupilumab is a monoclonal antibody therapy designed to treat immunological disease by blocking interleukin 4 and interleukin 13 receptor signaling-induced type 2 inflammation. DUPIXENT is approved for the treatment of asthma,…
On September 26, 2025, Factor Bioscience Inc. (“Factor”) filed a complaint against Cellectis Inc., Cellectis SA, AstraZeneca PLC, AstraZeneca Ireland Limited, and AstraZeneca Holdings B.V., alleging infringement of Factor’s U.S. Patent Nos. 10,662,410, 10,829,738, and 10,982,229. The case was filed in the District Court for the District of Delaware. Factor’s…
On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®. The updated vaccine targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. According to the announcement, the granted…
On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates. The applications for the two candidates, biosimilars to Amgen’s PROLIA (denosumab) and XGEVA (denosumab), respectively, cover “all indications covered by the reference…
On April 16, 2025, EmblemHealth, Inc. (“Emblem”) filed a class action suit in the District Court for the District of Massachusetts against Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) alleging Alexion “violated antitrust law by monopolistic acts that unlawfully delayed the introduction of biosimilar competition for…
On February 5, 2025 Valneva SE (“Valneva”) announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva’s chikungunya vaccine, IXCHIQ. IXCHIQ is a single-dose, live-attenuated vaccine indicated for active immunization against the chikungunya virus, and represents the first (and currently only) chikungunya vaccine. …
The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars. The CHMP recommended approval of four biosimilars developed by Celltrion: (1) AVTOZVMA (tocilizumab), for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced…