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" is available as a searchable, online database that contains information about all FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER), including biosimilar and interchangeable biological products, and a list containing information about all FDA-licensed biological products regulated by the Center for Biologics Evaluation.
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