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U.S. Food and Drug Administration
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  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Therapeutic Biologics Applications (BLA)
  7. Biosimilars
  8. Biosimilar Product Information
  1. Biosimilars

Biosimilar Product Information

The Food and Drug Administration approves biosimilar products and provides the scientific and regulatory advice needed to bring safe and effective biosimilars to market. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.

FDA-Approved Biosimilar Products

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The Purple Book Database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products. 

The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER).

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