FTC Issues Support Statement for FDA’s Draft Guidance on Interchangeable Biosimilars
The guidance, if finalized, would revise considerations about switching studies for proposed interchangeable biosimilars.
The Federal Trade Commission (FTC) has issued a statement in support of the FDA’s draft guidance on interchangeable biosimilars. The guidance includes further considerations about switching studies or studies that are intended to demonstrate a proposed product is interchangeable with the reference product, such as proposed interchangeable biosimilars.1,2
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In the guidance from May 2019, the FDA required the submission of single switching or multiple switching studies to show the interchangeability of the products in order to demonstrate biosimilarity. However, since the publication, the FDA stated, “Experience has shown that for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product.”2,3
In the new guidance, the FDA removes the prior recommendation of submitting clinical switching studies to demonstrate that a biosimilar is interchangeable with the reference product; however, the FDA is allowing the biosimilar drug applicant to submit a statement on why the existing data included for the biologic license application would support the interchangeability designation.1,2
The interchangeability designation was created by the Biologics Price competition and Innovation Act of 2009, stating that interchangeable biologics are biosimilar products that have the same clinical results as the reference products. With the designation, the biosimilar product can be substituted for the reference product by a pharmacists, instead of the prescriber—depending on state laws.4
In the FTC’s comment, the organization stated that the draft guidance could improve the approval process and reduce the burden and cost of biosimilar studies. The drafted guidance would also help to clear up any confusion regarding the safety and efficacy of biosimilars in comparison with the reference product. Further, the FTC stated that the guidance would also reduce barriers to entry and help expand the competition of biologic products, increasing the number of biosimilars with the interchangeability status.1
The FTC statement said, “The draft FDA guidance is a step in the right direction to fully realizing the goals of the Biologics Price Competition and Innovation Act of 2009 to increase competition and innovation among biologics, which could lead to lower prices and increased choice for patients who depend on these life-saving medicines.”1
Biosimilar products must demonstrate that it is highly similar to the reference product and not have clinically meaningful differences in safety, purity, and potency. In order for a biosimilar to be interchangeable, the data submitted in the biosimilar application/supplement should show that the biosimilar product produces the same clinical results 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.”2
In the new proposed guidance, applicants can choose to provide comparative analytics and clinical data that show support for the switching standard and applicants who have a pending biologic license application may choose to submit an amendment to the application and any additional information or data regarding the interchangeable biosimilar. The assessment should include information relevant to show that the risk from alternating or switching is not greater than using the reference product without switching.2
The draft guidance is finalized and is not a standalone guidance. The recommendations, if finalized, will revise the 2019 Interchangeability Guidance and replace certain sections in that guidance.2
