H.R. 9661: Expedited Access to Biosimilars Act

This bill would change how the FDA evaluates applications for biosimilar drugs, which are biological medicines designed to be highly similar to an already-approved reference product.

What the bill changes

• It would revise the Public Health Service Act to make clear that, by default, the FDA does not need to require clinical studies assessing pharmacodynamics or comparative clinical efficacy before licensing a product as biosimilar.
• Instead, the bill emphasizes other kinds of evidence, such as:
  • pharmacokinetics, which describes how a drug moves through the body, and
  • immunogenicity, which looks at whether the body’s immune system reacts to the product.
• The FDA would still be allowed to require additional clinical studies, including studies that assess pharmacodynamics or efficacy, but only if the agency determines those studies are necessary to show biosimilarity.
• If the FDA decides such studies are needed, it would have to provide written notice to the sponsor explaining that decision.

When the FDA would have to decide

• If the sponsor requests a biosimilar development meeting, the FDA would generally need to tell the sponsor whether extra clinical studies are needed by the time it grants that meeting request.
• If the FDA cannot make that determination at that time, it would need to explain that in writing.
• If no development meeting request is made, the FDA would need to make the determination within 60 days after the biosimilar application is submitted.

Other procedural change

• The bill would also repeal one existing requirement in the review provisions for biosimilar applications and renumber the remaining text accordingly. The practical effect appears to be a cleanup change tied to the revised review process.

When it would apply

• The changes would apply only to biosimilar applications submitted on or after the date the bill becomes law.

Relevant Companies

• None found