Biosimilars: BIO Comments on FDA Draft Guidance Labeling for Biosimilar Products

Re: Draft Guidance for Industry: Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643 (April 4, 2016))
The Biotechnology Innovation Organization (“BIO”) welcomes the opportunity to submit comments on the Food and Drug Administration’s (“FDA’s”) draft guidance entitled “Labeling for Biosimilar Products” issued on April 4, 2016 (“Draft Guidance”).
BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
Implementation of the Biologics Price Competition and Innovation Act (“BPCIA”) is of significant importance to BIO members, and we greatly appreciate FDA’s issuance of the long-awaited draft guidance on labeling of biological products licensed under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)). BIO is pleased to see the Agency’s recognition that a clear statement of biosimilarity provides essential information to inform the safe prescribing and use of biosimilar biological products. However, the proposed biosimilarity statement fails to convey critical information as to whether or not FDA has made a determination of interchangeability with the reference product. The failure to include such information risks creating confusion among prescribers, payers and other stakeholders regarding whether the biosimilar product has been determined to be interchangeable with the reference product.
Furthermore, we have significant concerns about a fundamental premise of FDA’s draft recommendations and some of the proposals that ostensibly flow from that premise. In finalizing the Draft Guidance, and in assisting applicants in developing draft labeling for biosimilar products, we strongly urge the agency to consider our comments and to implement the suggested changes.