The FDA announced a proposal to regulate biosimilars more like small-molecule generics, aiming to halve development time and lower costs substantially. Industry leaders including Stefan Glombitza (Formycon AG) hailed the potential $100 million-per-drug savings and expanded patient access. But biosimilar makers warn the U.S. Patent and Trademark Office is moving in the opposite direction: new guidance and denials of inter partes review (IPR) petitions narrow avenues to challenge patent thickets filed by originator biologic companies. The friction between FDA regulatory streamlining and patent-office tightening emerged in industry briefings and trade commentary, raising prospects of delayed market entry despite the agency’s push. For developers and payers, the tug-of-war matters because regulatory ease alone may not translate to price competition if patent-litigation and post-grant procedures remain restrictive. Stakeholders will watch forthcoming FDA guidance and PTO rulemaking for signals on whether biosimilar competition will meaningfully accelerate.