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In final interchangeability guidance . . .

FDA Okays Use Of Non-U.S. Biologics To Support Interchangeability

May 10, 2019
FDA has reversed policy and now says it will allow sponsors to use non-U.S.-licensed reference biologics in studies to support biosimilar interchangeability. However, the agency says sponsors that seek to use internationally-licensed reference products must provide data that establishes a bridge between the international comparator and the U.S.-licensed reference product. The agency’s shift, unveiled in a final guidance released Friday (May 10), is good news for the biosimilars industry, which had argued FDA’s previous stance against using non-U.S.-licensed reference products...


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