This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the…
This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the…
On October 17, 2025, Amgen and AstraZeneca announced that the FDA has approved an additional indication for TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled…
On October 9, 2025, the FDA approved Celltrion’s aflibercept biosimilar, EYDENZELT® (aflibercept-boav) referencing Regeneron’s EYLEA® (aflibercept). This approval makes Celltrion the…
On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”)…
On September 5, 2025, the U.S. District Court for the District of New Jersey entered a Consent Order and Judgment resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”)…
On September 30, the U.S. District Court for the Eastern District of Virginia granted in part and denied in part the Motion to Dismiss filed by Amgen, Inc. and Immunex…
On September 29, 2025, Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announced that the…
The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron Pharmaceuticals, Inc. (“Regeneron”) filing suit…
On September 16, 2025, the FDA approved Biocon Biologics Ltd.’s BOSAYA™ (denosumab-kyqq) and AUKELSO™ (denosumab-kyqq) as biosimilars to Amgen’s PROLIA® and XGEVA®, respectively. Both…
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099…