The Federal Trade Commission (FTC) has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance on interchangeable biosimilar drugs, which can be substituted for brand-name biologic products. The FTC stated that the FDA’s guidance would increase patient access to lower-cost prescription medications.
Biologic drugs, composed of large and complex molecules, treat serious medical conditions and are often among the most expensive types of prescription medications. A biosimilar drug is similar to a generic drug in that it treats the same conditions as a reference biologic or brand-name drug with no clinically meaningful differences, including in safety and effectiveness.
Under the FDA draft guidance, the requirement for clinical switching studies to demonstrate interchangeability with the biologic reference drug is removed. Instead, applicants may submit a statement explaining why existing data in a biologic license application supports designation as interchangeable. Once designated as “interchangeable,” pharmacists can substitute the biosimilar product without prescriber intervention.
The FTC supports this draft guidance, believing it will provide flexibility that may expedite approval processes and reduce costs associated with demonstrating safe and effective switching from a biologic to a biosimilar. The FTC's comment also noted that this guidance could help combat marketplace confusion about biosimilars' safety and efficacy. If implemented, it would likely reduce barriers to entry and facilitate competition among biologics by increasing the number of interchangeable biosimilars.
According to the FTC, this draft guidance aligns with the goals of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), aiming to increase competition and innovation among biologics, potentially leading to lower prices and more choices for patients relying on these medicines.
To ensure increased access to interchangeable biosimilars for Americans, agencies must continue monitoring anticompetitive practices that could hinder patient access if left unchecked. Contract terms discouraging generic drug insurance reimbursement undermine BPCIA's goals of fostering competition and innovation among biologics.
The Commission voted unanimously (5-0) to submit this comment to the FDA.
The Federal Trade Commission works to promote competition while protecting and educating consumers. The FTC advises against any demands for money or threats related to transferring money or promises of prizes. For more information on how competition benefits consumers or filing an antitrust complaint, follow FTC updates through social media, press releases, or their blog.
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