Long-awaited guidance setting out the US Food and Drug Administration’s approach to exclusivity for first interchangeable biosimilars will be published by the end of this year, according to a 2025 guidance agenda published by the agency’s Center for Drug Evaluation and Research.
FDA Promises Imminent Guidance On Interchangeable Biosimilar Exclusivity
Planned List For 2025 Also Includes Numerous Other Generics Guidances
The FDA’s CDER has set out a 2025 guidance agenda that promises long-awaited guidance on first interchangeable biosimilar exclusivity, as well as a host of other documents relevant to generic drug development and registration.
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