Tag: biosimilar approval

FDA Listing for Biosimilars: How They Are Evaluated and Approved

FDA Listing for Biosimilars: How They Are Evaluated and Approved

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The FDA doesn't rate biosimilars like generics - it uses a rigorous, multi-step process to prove they're highly similar and safe. Learn how biosimilars are approved, what 'interchangeable' means, and why so few reach the market.