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Purple Book Food and Drug Administration (FDA) Interchangeability

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more

Foley Hoag LLP

Are You Not Interchanged? FDA’s Recent Biosimilar Labeling Guidance Chips Away at Interchangeable Product Advantages.

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Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance. FDA justified its reversal on including the...more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

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As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

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