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On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.” The draft guidance is designed to “provide[] answers to commonly asked questions from applicants and other interested parties .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…
On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. TYENNE is the second FDA approved biosimilar of ACTEMRA (following Biogen’s TOFIDENCE (tocilizumab-bavi)…
As we have previously reported, in November 2023 Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed complaints against Celltrion, Samsung Bioepis and Formycon (collectively, “the Defendants”) in the U.S. District Court for the Northern District of West Virginia, alleging patent infringement under the Biologics Price Competition and Innovation Act (“BPCIA”) based on the…
On October 23, 2023, Celltrion announced FDA approval for ZYMFENTRA (infliximab-dyyb), a subcutaneous formulation for maintenance therapy for patients with moderately to severely active ulcerative colitis and Crohn’s disease. Infliximab is a TNF blocking agent that was first approved by the FDA as an intravenous formulation for the treatment of…
As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts, asserting that Biogen sought FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra®…
We previously reported on patent infringement litigations between Alnylam and Moderna. Below we provide updates on two proceedings involving the mRNA vaccine producer Moderna. First, in a patent action brought by Alnylam Pharmaceuticals, Inc. (“Alnylam”) against Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc. (collectively, “Moderna”), the parties entered a…
In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” and “Classification Categories for Certain Supplements under BsUFA III”, respectively. The “Formal Meetings between the FDA and…