Pharmacy Times November 17, 2023
The legal and common uses of “interchangeability” continue to be conflated.
With numerous adalimumab biosimilars launching in the United States in 2023, the impact of an FDA interchangeability designation has been extensively discussed with much speculation, but its commercial significance is yet to be determined. FDA is the only regulator in the world that has the legal authority to designate a biosimilar as interchangeable with its reference product, and this is stated on the biosimilar label. The FDA authority to designate biologics as “interchangeable” was created by the Biologics Price Competition and Innovation Act of 2009 enacted on March 23, 2010.1 According to the definition in that law, an interchangeable biologic is a biosimilar biological product that can be expected...
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