Expedited Access to Biosimilars Act

This bill changes what studies are required when companies seek approval for biosimilar medicines. It says clinical studies do not have to automatically test for immune reactions, how the drug works in the body, or head-to-head results against the original drug. Those extra tests can be required only if the Secretary decides they are needed and gives the company early written notice with reasons. Companies must still provide studies on how the body processes the drug to show it is safe, pure, and potent, and clinical studies in at least one appropriate use to show safety, purity, and potency.

• Who is affected: companies making biosimilar drugs and the Secretary overseeing approvals.
• What changes: no automatic requirement for immunogenicity, pharmacodynamics, or comparative clinical efficacy tests; these can be required only with early written justification. Pharmacokinetic and certain clinical studies are still required to show safety, purity, and potency.
• When: applies to applications filed on or after the date this act becomes law.