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 statutory provisions also may be referred to as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

To have a product reviewed as a biosimilar or interchangeable, manufacturers must submit a 351(k) biologics license application (BLA) that includes, among other things, information demonstrating biosimilarity based upon:

• Analytical studies demonstrating that the biological product is “highly similar” to the reference product notwithstanding minor differences in clinically inactive components;
• Animal studies (including the assessment of toxicity); and
• A clinical study or studies (including the assessment of immunogenicity and pharmacokinetics (PK) or pharmacodynamics (PD)) sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and for which licensure is sought for the biosimilar product.

FDA may determine, in its discretion, that an element described above is unnecessary in a 351(k) BLA. Therefore, we encourage manufactures to contact the appropriate review division to obtain input on a proposed development program.

For a product to be reviewed as an interchangeable product, manufacturers  must include information demonstrating biosimilarity, and include information to show that the proposed interchangeable product is expected to produce the same clinical result as the reference product in any given patient.  In addition, for a biological product that is administered more than once to an individual, a sponsor must include information to demonstrate that the risk in terms of safety or diminished efficacy of alternating or switching between use of the proposed interchangeable product and the reference product is not greater than the risk of using the reference product without such alternating or switching.

For any additional questions about the implementation of the BCPI Act and how it relates to an application, please contact:

• The Division of Drug Information  in the Center for Drug Evaluation and Research’s (CDER) Office of Communications  at 855-543-3784, 301-796-3400 or by email to druginfo@fda.hhs.gov , if the reference product for your proposed biosimilar biological product is regulated by CDER.

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