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…
The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron Pharmaceuticals, Inc. (“Regeneron”) filing suit under the Biologics Price Competition and Innovation Act (“BPCIA”) against Amgen Inc. (“Amgen”), Mylan Pharmaceuticals Inc. (“Mylan”), Biocon Biologics Inc. (“Biocon”), Celltrion, Inc. (“Celltrion”), Formycon AG (“Formycon”),…
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 26, 2025, Factor Bioscience Inc. (“Factor”) filed a complaint against Cellectis Inc., Cellectis SA, AstraZeneca PLC, AstraZeneca Ireland Limited, and AstraZeneca Holdings B.V., alleging infringement of Factor’s U.S. Patent Nos. 10,662,410, 10,829,738, and 10,982,229. The case was filed in the District Court for the District of Delaware. Factor’s…
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…
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 (“the ’099 patent”). The ‘099 patent issued on June 17, 2025, almost eight months after Amgen announced the launch of PAVBLU on…
On September 17, 2025, Alvotech USA Inc. and Alvotech hf. (“Alvotech”) filed a Petition for Post Grant Review of U.S. Patent No. 12,168,036 (“the ‘036 patent”), assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”). The ‘036 patent, entitled “Methods for treating angiogenic eye disorders with high doses of VEGF receptor fusion proteins,”…
This month, FDA issued its new final guidance to replace a draft guidance that issued on May 22, 2019 titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry”. This final guidance outlines the FDA’s “recommendations on the design and evaluation of comparative analytical…
The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds. Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal government. With the increasing market share of more expensive biologic prescriptions, those…
On September 9, 2025, the District Court for the Northern District of West Virginia entered a Stipulation and Order dismissing all claims and counterclaims in view of a settlement agreement between Sandoz, Inc. (“Sandoz”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) resolving the BPCIA litigation regarding Sandoz’s aflibercept biosimilar, ENZEEVU (aflibercept-abzv). According…