The FDA announced plans to streamline biosimilar approval pathways to mimic generic regulation, promising lower development costs and faster market entry. Industry leaders touted potential savings of up to $100 million per program, but biosimilar makers warned the U.S. Patent and Trademark Office (USPTO) under current leadership has tightened inter partes review (IPR) and narrowed avenues to challenge brand patents. The friction threatens to blunt the FDA’s regulatory gains and could delay competition for high-cost biologics. The report cites comments from FDA leadership and industry executives and details how extended patent thickets and reduced IPR success rates raise legal and commercial barriers despite favorable agency guidance.