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”).
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Regeneron Files Another Complaint Against Amgen in Aflibercept BPCIA Litigation
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,…
Biosimilar Manufacturers to Expand Offerings in Europe and Japan
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. …
Third Circuit Holds That Granting Discovery Under Section 1782 Is Not a “Final” Judgment
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…
Sandoz Launches PYZCHIVA® (Ustekinumab) Autoinjector in Europe
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 Secures Marketing Approval in Korea for its Biosimilar to Amgen’s Bone Cancer Drug Xgeva
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…
EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars
By Sam Herron
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)…
Celltrion, Samsung Bioepis, and Organon Receive Interchangeability Designations for Adalimumab Biosimilars
By Emma Murray
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…
FDA Approves Bio-Thera and Hikma’s Ustekinumab Biosimilar
By Riley Wyberg
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,…
FDA Approves BLA for Novavax’s COVID-19 Vaccine
By Tara Thigpen
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…