FDA Updates 2015 Biosimilars Guidance

The FDA issued draft guidance updating its 2015 biosimilars guidance to streamline and accelerate approvals by reducing or eliminating the need for comparative clinical‑efficacy studies when robust comparative analytical assessments plus targeted pharmacokinetic and immunogenicity testing demonstrate high similarity. HHS officials — Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary and CMS Administrator Dr. Mehmet Oz — said the move aims to cut regulatory barriers, boost competition and speed lower‑cost biosimilars to market, noting biologics account for a small share of prescriptions but a large share of U.S. drug spending. The draft specifies conditions (for example, clonal cell lines and highly purified products) under which clinical trials may not be necessary and argues well‑conducted analytical comparisons can be more sensitive than clinical studies. It encourages easier pharmacy substitution and will be open for about a 60‑day public comment period before regulators issue nonbinding final guidance in the coming months. Industry groups and analysts welcomed the emphasis on access and affordability but warned that patent litigation, insurer coverage decisions, interchangeability rules and slow pharmacy uptake — among other market barriers — may limit near‑term price relief for biologics such as Humira, Herceptin and Lantus.