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Guidance Update › Food and Drug Administration (FDA) › Interchangeability

Venable LLP

FDA Revises Guidance on Switching Studies for Biosimilar Interchangeability

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On June 20, 2024, the FDA issued a draft guidance, “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the need for switching studies to demonstrate a biosimilar is...more

Goodwin

FDA Updates Draft Guidance on Promotional Communications of Prescription Biologics and Biosimilars

Goodwin on

On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more

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