Lexology May 23, 2024
The U.S. Food and Drug Administration (FDA) recently released a podcast on biosimilars, featuring Dr. Sarah Yim, director of FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB), that seems to indicate a potential move away from differentiating non-interchangeable biosimilars and interchangeable biosimilars. This comes on the heels of several actions taken by FDA and the Biden administration that also reflect a “flattening” of the biosimilar and interchangeable biosimilar regulatory framework. Below we analyze these recent actions, including the agency’s updated promotional labeling draft guidance for biosimilars and interchangeable biosimilars.
Under the Biologics Price Competition and Innovation Act (BPCIA), a “biosimilar” product is one that is demonstrated to be “highly similar” to the reference product with “no clinically meaningful differences [from...
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