The US Food and Drug Administration recently released its long-awaited draft guidance addressing the standards for demonstrating interchangeability of biological products under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). 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. This Legal Update takes a close look at the draft guidance, which calls, among other things, for developers of biosimilars to use switching studies when they wish to demonstrate that a biosimilar product is interchangeable with a reference product and will produce the same clinical result with no greater risk.

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