FDA Finally Addresses Interchangeable Biosimilars

Law360, New York (February 28, 2017, 11:54 AM EST) -- Christopher M. Mikson

Mark Mansour

Emily K. Strunk The U.S. Food and Drug Administration recently issued long-awaited draft guidance, "Considerations in Demonstrating Interchangeability With a Reference Product" (January 2017), addressing the standards for demonstrating interchangeability of biological products under the Biologics Price Competition and Innovation Act of 2009.

The BPCIA amended the Public Health Service Act to create an abbreviated pathway for FDA licensure of biologics that are biosimilar to, or interchangeable with, a reference product. Under the BPCIA, a product is biosimilar if it is highly similar to the reference product, notwithstanding minor differences in clinically inactive components and if...

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