Statement from FDA on Policy Advancements to Help Bring Interchangeable Biosimilars to Market

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 market in the future. There are currently no approved insulin products that can be substituted at the pharmacy level. But, under the BPCI Act, on March 23, 2020, insulin and other biological products that were approved as drugs under the Federal Food, Drug, and Cosmetic Act will be deemed biological products licensed and regulated under the PHS Act. After this transition, the FDA will be able to license biosimilar and interchangeable insulin products that meet the requirements of the PHS Act, and today’s guidance will, among other things, help developers seek licensure for such products.

An interchangeable insulin product may be substituted at the pharmacy, potentially leading to increased access and lower costs for patients. For chronically used biologic medications patients get at the pharmacy, such as insulin, the ability to have a licensed interchangeable that can be substituted at the pharmacy without the intervention of the prescribing health care professional – much like how generic drugs are routinely substituted for brand name drugs – could be integral to the success of reducing drug prices for patients.

Next week, the agency will hear from patients, advocates and industry about what factors the agency should consider when evaluating data and other information submitted by an applicant, including from analytical and clinical studies, to determine whether an insulin product is biosimilar to or interchangeable with a reference product. We also expect to hear stakeholder feedback on whether certain insulin products – for example, those that use insulin pumps for continuous subcutaneous infusion among the approved uses – raise unique scientific considerations that we should be considering when evaluating biosimilar or interchangeable insulin products. And importantly, we’ll also be seeking input directly from patients about their experience with insulin products and this input will inform the FDA’s approach to implementing the regulatory pathway for biosimilar and interchangeable insulin products.

In advancing the broader policy efforts for biosimilar and interchangeable products, soon we will also be issuing additional guidance on the agency’s recommendations on the design and evaluation of comparative analytical studies and other important scientific considerations needed to support a demonstration that a biological product is biosimilar to a reference product. This data will help build the foundation for a development program for a proposed biosimilar or interchangeable product.

To date, the FDA has already licensed 19 biosimilar products, which should help strengthen competition in the biologic market. This, and other work we are undertaking as part of the Biosimilars Action Plan, is building a solid regulatory foundation for the review and approval of biosimilar and interchangeable biologics designed to improve patient access to lower-cost options.

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