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U.S. Department of Health and Human Services

Drugs

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Information for Industry (Biosimilars)

The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product.  These new statutory provisions also may be referred to as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

As the FDA moves forward in our implementation of the BPCI Act, we recommend that any product sponsor that has any questions regarding the BPCI Act contact the appropriate review division to obtain input on its proposed development program. 

If the reference product for your proposed biosimilar biological product is regulated by the Center for Drug Evaluation and Research (CDER), contact the Biosimilars Program Staff in CDER’s Office of New Drugs (301-796-0700).

If the reference product for a proposed biosimilar product is regulated by the Center for Biologics Evaluation and Research (CBER), contact the Office of Communication, Outreach and Development (OCOD) at 800-835-4709 or 301-827-1800 or by email to ocod@fda.hhs.gov.

Resources will be posted in this section as they become available to answer regulatory and drug-related questions.