Expedited Access to Biosimilars Act

Key Points

• The bill changes the default rule for approving biosimilars, generic-style versions of biologic drugs, so that large clinical trials testing pharmacodynamics or efficacy are no longer automatically required.
• FDA can still demand an extra clinical study, but only if it decides the study is actually necessary to prove the biosimilar matches the original drug, and it must explain that decision in writing to the drug company.
• FDA has strict deadlines to notify companies about extra testing requirements, either when it agrees to a development meeting or within 60 days of the application being filed.
• The new rules would only apply to biosimilar applications filed on or after the bill becomes law, so drugs already in the approval pipeline would not be affected retroactively.