The Food and Drug Administration says it is taking significant action to help promote competition in the biologic market by providing final guidance on the pathway for interchangeable biologics, which FDA says may be substituted without the involvement of the prescriber. According to FDA’s announcement, this would be 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 agency said the 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).
To date, the FDA has already licensed 19 biosimilar products, which should help strengthen competition in the biologic market.
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 healthcare 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.
The 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.
“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, said Acting FDA Commissioner Ned Sharpless, in the statement. “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 [this] guidance will, among other things, help developers seek licensure for such products.”
On May 13, the agency solicited comments 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. The agency said will 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.
