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)…

In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars.  Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without intervention of the prescribing health care provider.
 
On May…

On May 22, 2025, the FDA approved Bio-Thera Solutions and Hikma Pharmaceuticals’ ustekinumab biosimilar, STARJEMZA® (ustekinumab-hmny) injection, referencing Janssen’s STELARA® (ustekinumab) injection.  This approval makes Bio-Thera the seventh company to receive FDA approval for an ustekinumab biosimilar, joining Amgen,…

On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64 years with at least one underlying condition…

On May 13, 2025, Biogen Inc. and Biogen MA Inc. (“Biogen”) filed a Complaint for Declaratory Judgment and Permanent Injunctive Relief against Neurimmune Holding AG and Neurimmune SubOne AG (“Neurimmune”) in the U.S. District Court for the District of Massachusetts. …

On May 14, 2025, HyClone Laboratories, LLC (“HyClone”) filed a Motion to Quash in the U.S. District Court for the District of Utah, seeking to quash Amgen Inc.’s (“Amgen”) subpoena to HyClone issued in Amgen’s denosumab BPCIA case against Accord.…

On May 15, 2025, a jury returned a verdict finding Amgen Inc. (“Amgen”) liable for antitrust violations and awarding Regeneron Pharmaceuticals, Inc. (“Regeneron”) over $400 million in damages.
As we reported previously, Regeneron filed its antitrust lawsuit in 2022 in…