FDA Announces Public Meeting on Approval Pathways for Biosimilars

Oct 20, 2010   
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The U.S. Food and Drug Administration (FDA) has announced that it will hold a two-day public hearing on November 2-3, 2010 for the purpose of gathering “input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).”

The Patient Protection and Affordable Care Act (Pub. L. 111-148), signed into law by President Obama in March of this year, contains the BPCI Act. The BPCI Act amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products. In order to take advantage of this abbreviated pathway, these biological products must be shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product.

Biosimilarity may be demonstrated through the use of scientific support (clinical trials, animal studies, etc.) with the appropriate number of trials and appropriate types of studies. The appropriate number and type required will be determined by the FDA. For a product to be considered biosimilar, data collected from the requisite study/studies must show that the biological product is “highly similar to the reference product, notwithstanding minor differences in clinically inactive components.” While it is unclear what level of clinical similarity is required to reach the finding of “highly similar”, The Agency intends to address this issue during the November hearing.

For more information on biologics or the BPCI Act, contact us at contact@fidjlaw.com.