U.S. regulators announced a plan to streamline approval of biosimilars to make copycat biologics cheaper and faster to market, but industry officials warn the U.S. Patent and Trademark Office is constraining competition. FDA Commissioner Marty Makary proposed treating biosimilars more like generics to cut development time and cost. Formycon CEO Stefan Glombitza told reporters the shift could save developers up to $100 million per drug. Industry sources told reporters the Patent Office’s recent tightening of inter partes review (IPR) procedures and denials of IPR petitions are creating a new bottleneck: patent barriers remain intact even as the FDA lowers clinical and regulatory hurdles. The tension between expedited FDA guidance and patent-litigation limits could delay lower-cost biosimilars from reaching patients, especially for blockbuster biologics with dense patent thickets.