Biosimilars Forum Seeks ‘Flexible’ Interchangeability Approach
The Biosimilars Forum has urged FDA to be more flexible with its approach in determining a proposed biosimilar product’s interchangeability with an innovator’s product. In comments addressing the agency’s recent draft guidance on Considerations for Demonstrating Interchangeability with a Reference Product, the organization urges FDA to consider, on a case-by-case basis, the practicality and feasibility of switching study expectations to support a determination of interchangeability, and to ensure there is flexibility in approach when appropriately justified. The group believes it is important for the agency to “clarify that a demonstration of interchangeability represents a distinct requirement for additional data compared to a demonstration of biosimilarity. It is important for stakeholders across the health care industry to understand that the FDA does not have more than one standard of product quality for the approval of biologics and that the safety and efficacy profiles of biosimilars and their corresponding interchangeable biologics are the same.”
The draft guidance (see earlier story) says FDA “intends to consider the totality of the evidence provided by a sponsor when the agency evaluates the sponsor’s demonstration of interchangeability according to the criteria set forth in the BPCIA [Biologics Price Competition and Innovation Act].” It also notes that the data and information to support a showing that the proposed interchangeable product can be expected to produce the same clinical result as the reference product in all the reference product’s licensed conditions of use may vary depending on the nature of the proposed interchangeable product.
Additionally, the forum says that several terms appear in the guidance that have not been well-defined. Additionally, there are concepts which are not addressed that the forum considers would be beneficial for the FDA to directly and proactively define. The group says industry and the public would benefit from the adoption of a glossary to define particular terms related to interchangeability that would supplement the definitions provided in the recently finalized FDA guidance.