On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”).  The ’099 patent issued on the same day,…

On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe.
Samsung Bioepis announced a licensing, development, and commercialization agreement with NIPRO Corporation for multiple biosimilar candidates in Japan. …

The U.S. Court of Appeals for the Third Circuit recently issued an opinion holding that when a district court has ordered discovery under 28 U.S.C. § 1782, but has not yet conclusively defined the scope of that discovery, the decision…

On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.”  PYZCHIVA®—a biosimilar of Janssen’s STELARA®—is approved for the treatment of adults with plaque psoriasis, psoriatic…

Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and to treat rare conditions…

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…