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...more
On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more
On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation...more
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...more
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....more
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,...more
In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” and...more