Limits when the FDA can require clinical studies on pharmacodynamics or efficacy before approving a biosimilar biological product, and requires the agency to explain each such requirement in writing.

• Allows the FDA to require pharmacodynamics or efficacy studies only when it issues a written determination that they are necessary to show biosimilarity.
• Requires the FDA to issue that determination in meeting minutes or within 60 days after an application is submitted.
• Bars the FDA from adding these study requirements later, except by written agreement with the sponsor or after a scientific justification, a detailed written explanation, and a development meeting on request.
• Applies to applications submitted on or after the date of enactment.

• Health, Education, Labor, and Pensions Committee (Senate)

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