FDA guidance may ease path to biosimilar interchangeability

On 10 May 2019 the U.S. Food and Drug Administration (FDA) published the final guidance, "Considerations in Demonstrating Interchangeability With a Reference Product," which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable with a reference product.

Even as some of the details remain to be hashed out, the guidance makes clear FDA's desire to minimize the burdens of obtaining a determination of interchangeability. The guidance summarizes the important scientific considerations for demonstrating interchangeability.

Read More: FDA guidance may ease path to biosimilar interchangeability


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