U.S. FDA has released a draft guidance for industry outlining criteria for demonstrating that a biosimilar is interchangeable with a reference product under section 351 (k) of the Public Health Service Act.
This new guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under section 351(k) of the Public Health Service Act (PHS Act) (42 20 U.S.C. 262(k)).
Section 351(k) of the PHS Act, as amended by the BPCI Act, sets forth the requirements for an application for a proposed biosimilar product and an application or a supplement for a proposed interchangeable product. Section 351(k)(4) of the PHS Act further provides that upon review of an application submitted under section 351(k) or any supplement to such an application, FDA will determine the biological product to be interchangeable with the reference product if FDA determines that the information submitted in the application or the supplement is sufficient to show that the biological product “is biosimilar to the reference product” and “can be expected to produce the same clinical result as the reference product in any given patient” and that “for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.”
To support a demonstration of interchangeability, section 351(k)(4)(A) of the PHS Act provides, that a sponsor must show that the proposed product “is biosimilar to the reference product.” Where a product is first licensed as a biosimilar, that licensure may be referenced to support a showing for this statutory criterion for demonstrating interchangeability.
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
You can check the draft guidance from here.