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”) and Biocon Biologics, Inc., Biocon Biologics UK Limited, Biocon Biologics Limited, and Biosimilars Newco Limited (collectively, “Biocon”) after Amgen and Biocon executed a Confidential…
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”) and Samsung Bioepis Co., Ltd. and Samsung Biologics Co., Ltd. (“Samsung”), one day after Amgen and Samsung executed a Confidential Settlement…
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 FDA approved their biosimilar denosumab products Enoby and Xtrenbo (denosumab-qbde), referencing Prolia and Xgeva respectively. This marks the seventh biosimilar denosumab approval. Hikma and…
In the past few weeks, several biosimilar products have been granted marketing authorization in Europe and Japan, and additional products have been recommended for approval in Europe. The European Commission Approves Henlius and Organon’s Denosumab Biosimilars: On September 19, 2025, Shanghai Henlius Biotech and Organon announced that the European Commission…
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 biosimilars have been approved for all indications of their reference products and granted provisional interchangeability designations. BOSAYA™ and AUKELSO™ are RANK ligand inhibitors used to treat…
On September 2, 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the FDA has approved BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp) as denosumab biosimilars to Prolia® and XGEVA®, respectively. Both biosimilars have been approved for all indications of their reference products. BILDYOS® and BILPREVDA® are RANK ligand inhibitors used to treat…
On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and only interchangeable biosimilar to Novo Nordisk’s NOVOLOG (insulin aspart injection) in the United States. KIRSTY is…
On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”) resolving the BPCIA litigation regarding Accord’s denosumab biosimilar, INTP23. Pursuant to the agreement, Accord will be…
On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. WYOST® and Jubbonti® are the first and only interchangeable FDA-approved denosumab biosimilars and are approved to treat all indications of the reference medicines, XGEVA® and Prolia®. The FDA approved WYOST®…
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. On June 25, 2025, Amgen filed a complaint in the U.S. District Court for the District of New Jersey against Hikma Pharmaceuticals USA Inc. (“Hikma”),…