The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment. While the exact contents of this guidance are unclear, prior FDA labeling guidance may offer some clues as to FDA’s approach.
Regulatory Context: Biosimilars and Interchangeability
The FDA was first authorized to develop a pathway for the approval of biosimilar products in 2010 under the Biologics Price Competition and Innovation (BPCI) Act. Biosimilars are biological products that are highly similar to a previously approved biological product and have “no clinically meaningful” differences relative to the original reference product.
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