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A Look at FDA's Proposed Changes to Labeling for Biosimilars and Interchangeable Biosimilars | Foley & Lardner LLP

The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information. ....

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New FDA Guidance Removes Interchangeability Statement from Product Labels | Venable LLP

On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for. ....

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Are You Not Interchanged? FDA's Recent Biosimilar Labeling Guidance Chips Away at Interchangeable Product Advantages. | Foley Hoag LLP

Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance. . ....

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Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1)

Biosimilarity ....

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Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid | King & Spalding

Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid | King & Spalding
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