Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”) of Regeneron’s U.S. Patent No. 11,084,865 (the “’865 patent”). The ’865 patent issued on August 10, 2021 and is…
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. One of these candidates is SB17, a biosimilar of Janssen’s…
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 is not “final” and thus may not be appealed under…
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 arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six…
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 like unresectable giant cell tumors. Earlier this year, Samsung also…
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) and XGEVA (denosumab), respectively, cover “all indications covered by the reference…
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 23, Celltrion announced that the FDA granted an expanded interchangeability designation…
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, Alvotech, Samsung, Fresenius, Accord, Biocon, and Celltrion. Ustekinumab is a human…
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 putting them at high risk for severe outcomes. Novavax previously…
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. Biogen alleges that Neurimmune wrongfully attempted to “lay claim to…