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…
On November 8, 2024 Autolus, Inc. (“Autolus”) announced that the FDA has approved AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”). AUCATZYL is a CAR T cell therapy designed to specifically recognize and bind CD19-positive B-cells in precursor ALL…
On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the fourth BPCIA litigation regarding denosumab, following Amgen’s litigations against Sandoz, Celltrion, and…
As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to establish the Drug Price Negotiation Program (“the Program”; see here for a full recap of the Program’s…
On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.” The draft guidance is designed to “provide[] answers to commonly asked questions from applicants and other interested parties . . . regarding postapproval manufacturing changes . ….
As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court for the District of Delaware, alleging infringement of six patents under the BPCIA based on Samsung’s submission of its BLA for…
On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation. As we previously reported, Fresenius Kabi received FDA approval for both intravenous and subcutaneous formulations on March 5, 2024, making TYENNE the first tocilizumab biosimilar approved in both formulations. TYENNE is…