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Biologics Scientific Evidence

Hogan Lovells

FDA guidance may ease path to biosimilar interchangeability

Hogan Lovells on

On Friday, 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...more

McCarter & English, LLP

FDA Issues Draft Guidance on Demonstrating Interchangeability Under the BPCIA

On January 17, 2017, the Food and Drug Administration (FDA) issued its long-awaited draft guidance on licensure as an interchangeable biological product approved under the Biologics Price Competition and Innovation Act of...more

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