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Data Requirements for Biosimilars

  Рет қаралды 26,732

U.S. Food and Drug Administration

U.S. Food and Drug Administration

6 жыл бұрын

FDA-approved biosimilars require data from multiple studies and analytical tools to demonstrate analytical similarity to reference products. Learn more with Dr. Steve Kozlowski, M.D., Director at FDA’s Center for Drug Evaluation and Research. For more information, visit www.FDA.gov/bi...

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