The FDA announced plans to streamline biosimilar approvals to mirror generic drug pathways, aiming to cut time and cost for biosimilar developers. Industry executives said the policy could reduce development costs by up to $100 million per product and expand competition for high‑cost biologics. However, biosimilar makers warn the U.S. Patent and Trademark Office (USPTO) is tightening access to inter partes review (IPR) challenges, which could blunt the FDA’s reforms by preserving patent thickets around brand biologics. Stakeholders including Formycon AG and policy analysts characterized the situation as regulatory cross‑purposes: FDA easing scientific standards while patent processes increasingly favor originators.