On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), announced a new strategy aimed at dramatically reducing the cost and timeline of biosimilar development (U.S. Food and Drug Administration,FDA Moves to Accelerate
Introduction
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This initiative formalizes the agency’s long-building effort to incorporate New Approach Methodologies (NAMs) into regulatory review and follows the release of draft guidance
With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close analogs of existing reference blockbuster branded products. This post provides a roadmap into this evolution, focusing on potential biosimilar approvals and launches
Introduction
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to enhance the efficacy and accuracy of the drug approval process, ensuring that applications incorporating AI meet rigorous
As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified Patent Court (UPC) first decision – invalidating EP Patent No. 3,666,797 B1 – and provided a summary of that case. This analysis will focus
As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. Thus, we reviewed the UPC’s first decision and provide a summary of the first revocation of a European patent by the new Unified Patent Court (UPC).
Please note that