The FDA announced a proposal to streamline biosimilar regulation to mirror generic drug pathways, aiming to cut development time and cost for copycat biologics. Industry leaders including Stefan Glombitza of Formycon applauded potential savings up to $100 million per drug. However, stakeholders warn the U.S. Patent and Trademark Office’s recent narrowing of inter partes review (IPR) and denials of IPR petitions could leave biosimilar makers unable to challenge extensive patent portfolios filed by originator companies. Analysts say the regulatory gains from FDA guidance may be undermined if patent challenges become more difficult, slowing competition and preserving high biologic prices.