Pharma IP & Biosimilars Update (May 2026): Landmark Denosumab Approvals and Europe’s Latest SPC Ruling-Safinamide
Pharma IP & Biosimilars Update (May 2026): Landmark Denosumab Approvals and Europe’s Latest SPC Ruling Introduction The global pharmaceutical landscape continues to shift as high-stakes biologics face biosimilar competition and European patent courts redefine market exclusivity. This week, we analyse the surge in FDA-approved denosumab biosimilars , a strategic PBM formulary disruption , and a major legal reversal in Germany that leaves generic manufacturers exposed to patent infringement risks . 1. The Denosumab Market Explodes: 2026 FDA Biosimilar Approvals The early months of 2026 have marked an incredibly active period for bone-health therapies . The FDA has granted several key approvals that are fundamentally reshaping the denosumab competitive landscape . New 2026 Approvals & Dual-Brand Strategies Boncresa & Oziltus (denosumab-mobz): Approved on January 6, 2026, developed by Amneal and mAbxience . Amneal is deploying a dual-brand approach to target specific healt...