The U.S. Food and Drug Administration (FDA) plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars, and interchangeable biologics.
The FDA is taking a significant action that will help promote competition in the biologic market by providing final guidance on the pathway for "interchangeable" biologics, which may be substituted without the involvement of the prescriber, similar to how generic drugs are routinely substituted for brand name drugs when they are prescribed for patients. Biologics provide important treatment options for patients with serious diseases like cancer, rheumatoid arthritis, diabetes and multiple sclerosis. The FDA’s final guidance on interchangeability will provide clarity for developers who want to demonstrate that their proposed biological product meets the statutory interchangeability standard under the Public Health Service Act (PHS Act).
In the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), Congress created an approval pathway for biological products that are demonstrated to be "biosimilar" to or "interchangeable" with an FDA approved biological brand (or reference) product. This pathway is intended to benefit patients by making more treatment options available through biosimilar and interchangeable products, by increasing access to life-saving medications and potentially lowering health care costs through competition. Because well-functioning biosimilar and interchangeable pathways are critical to the agency’s broader efforts to improve competition, the FDA has developed and is working to implement a Biosimilars Action Plan that includes a suite of ongoing efforts to encourage innovation and competition among biologics and the development of biosimilars.
Today’s final guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product. Once an application or supplement seeking licensure as an interchangeable product is submitted, the FDA will approve the biological product as interchangeable with the reference product if the information submitted in the application or the supplement is sufficient to meet the applicable statutory standard: among other things, 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. The guidance also explains potential ways to address the BPCI Act requirement for interchangeability 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 will not be greater than the risk of using the reference product without such alternation or switch.
The final interchangeability guidance is informed by the FDA’s cumulative experience providing development-stage advice to sponsors of proposed interchangeable products. The FDA meets regularly with sponsors of proposed interchangeable products through the agency’s Biosimilar Product Development Program. The agency also considered the numerous comments on the draft interchangeability guidance and made changes to provide increased clarity to stakeholders. Our rigorous scientific standards for approval will be maintained for interchangeable biologics and should serve as assurance to health care professionals and patients that they can be confident in the safety and effectiveness of both interchangeable products and biosimilar products, just as they would be for reference products.
Separately, and of particular importance to the millions of Americans with diabetes, the final interchangeability guidance will help enable biosimilar or interchangeable insulin products to come to...
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