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U.S. Department of Health and Human Services


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August 28: Can you tell us about the FDA's position on biosimilars?

CDER Director

Biological products are therapies used to treat diseases and health conditions. They include a wide variety of products including vaccines, blood and blood components, gene therapies, tissues, and proteins. Unlike most traditional, small-molecule prescription drugs that are made through chemical processes, biological products are generally made from human and/or animal materials.

Under the Public Health Service Act, a biological product may be demonstrated to be “biosimilar” to an approved biologic product if data show that, among other things, the product is “highly similar” to that product. Biosimilar versions of currently approved biological products have the potential to enhance competition and may lead to better patient access and lower consumer costs.

When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process. Earlier this year, we issued three draft guidance documents on biosimilar-product development to assist industry in developing such products in the United States.

You can be assured that FDA will require licensed biosimilar and interchangeable biological products to meet the Agency’s exacting standards of safety and efficacy.