Expedited Access to Biosimilars Act

This bill changes the federal rules for approving biosimilar drugs, which are biological products shown to be highly similar to an already-licensed biological product. It provides that clinical studies assessing pharmacodynamics or efficacy are not expected by default for approval. The Secretary of Health and Human Services could require such additional clinical studies only after determining they are necessary to show biosimilarity and giving the applicant written notice by a set deadline. The bill also repeals a separate review-related requirement in the law, and the new study rules apply to applications submitted on or after the bill becomes law.

Full text and official record on Congress.gov

Sponsors

• Nicholas A. Langworthy Republican sponsor
• 2 cosponsors