FDA Issues Draft Guidance to Speed Biosimilar Approvals

The FDA issued draft guidance to streamline biosimilar approvals by reducing reliance on large comparative‑efficacy clinical trials when rigorous comparative analytical assessments, human pharmacokinetic similarity and immunogenicity data demonstrate high similarity for certain well‑characterized biologic products. Health Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary and CMS Administrator Mehmet Oz said the move aims to cut bureaucracy, increase competition and speed lower‑cost biosimilars to market, noting biologics account for roughly 5% of prescriptions but more than half of U.S. drug spending and that biosimilars can cost about half as much. The guidance also encourages easier pharmacy substitution and specifies conditions (for example, clonal cell lines and highly purified products) under which clinical trials may not be necessary. The draft will be open for a 60‑day public comment period, with a nonbinding final guidance expected in three to six months. Officials and analysts cautioned that actual price relief will depend on reimbursement policies, interchangeability rules, pharmacy uptake and remaining legal or market barriers.