Biosimilars: Approval Process
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YouTubeU.S. Food and Drug Administration
Biosimilars: Approval Process
The abbreviated approval pathway for biosimilars was created to help reduce the time and cost of development of biologics without compromising safety and effectiveness. This video provides an overview of the biosimilar development program and the FDA’s rigourous standards for approval. For more information, visit www.FDA.gov/biosimilars.
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