On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®, respectively. The FDA also granted a provisional determination for both OSPOMYV and XBRYK’s interchangeability designation. These approvals make Samsung the…
On February 6, 2025, Dr, Reddy’s Laboratories SA (“Dr. Reddy’s”) announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (“Henlius”) for the development and commercialization of Henlius’s HLX15 (daratumumab), a biosimilar candidate to Janssen’s Darzalex® & Darzalex Faspro®. HLX15 (daratumumab) is a recombinant anti-CD38 fully…
On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of SIMPONI®, in the United States. According to the agreement, Bio-Thera will maintain responsibility for the development, manufacturing, and supply of BAT2506, while…
On February 4, 2025, HyClone Laboratories, LLC (“HyClone”), a cell culture media supplier, filed a Motion to Quash a subpoena issued by Amgen, Inc. (“Amgen”). The underlying subpoena was issued in Amgen’s ongoing denosumab BPCIA litigation against Fresenius Kabi USA, LLC and its affiliates (“Fresenius”) in the District Court for…
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizations for three biosimilar products—Amgen’s PAVBLU and SKOJOY, and CuraTeQ Biologics’ DYRUPEG. Amgen’s PAVBLU and SKOJOY, both biosimilars referencing EYLEA…
On February 3, 2025, BioNTech SE (“BioNTech”) confirmed the completion of its acquisition of biotechnology company Biotheus for an upfront payment of $800 million and up to $150 million in potential milestone payments. Biotheus will operate as an indirect Chinese subsidiary of BioNTech. Under the terms of the agreement, BioNTech…
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd. (“Samsung”) and Formycon AG (“Formycon”) from marketing their aflibercept biosimilars of EYLEA®. The district court granted preliminary injunctions…
On February 2, 2025, Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentech’s PERJETA. This marks the first U.S. BLA acceptance for a pertuzumab biosimilar, a targeted therapy for select patients with HER2-positive breast cancer. Pertuzumab is currently indicated by…
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. The document clarifies how sponsors, manufacturers, and other industry developers should approach artificial intelligence (AI) to support safe, effective development and marketing of AI-based…
On January 31, 2025, Celltrion announced that the FDA approved its tocilizumab biosimilar, AVTOZMA® (tocilizumab-anoh), referencing Genentech’s ACTEMRA®. Tocilizumab is a monoclonal antibody that can act as an interleukin-6 (IL-6) inhibitor to reduce inflammation in the body. The FDA approved AVTOZMA® for subcutaneous injection or intravenous infusion for treatment of…