Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies

Docket Number:: FDA-2011-D-0605
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research, Office of New Drugs, Office of Therapeutic Biologics and Biosimilars

FDA is posting this document to provide advance notice to the public. After the lapse in appropriations ends, a notice of availability for the guidance will be published in the Federal Register, which will detail how to submit comments on this document.

This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application under the Public Health Service Act (PHS Act).

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All written comments should be identified with this document's docket number: FDA-2011-D-0605.

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