The FDA proposed guidance to streamline biosimilar approvals—aiming to slash time and cost for copycat biologics—while critics say the U.S. Patent and Trademark Office’s tougher stance on inter partes review (IPR) will block market entry. Industry groups warned that narrowing IPR opportunities undermines a key pathway biosimilar developers used to challenge extensive brand‑name patent thickets. The regulatory split could slow competition for high‑cost biologics despite the FDA’s internal moves to treat biosimilars more like conventional generics. Biotech executives stressed that coordinated regulatory and patent solutions will be necessary to realize meaningful price reductions and expand patient access.