FTC supports FDA guidance on interchangeable biosimilar drugs

The USA’s Federal Trade Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs that can be substituted for brand-name biologic products, stating that the FDA’s guidance would increase patient access to lower-cost prescription medications.

Under the FDA draft guidance, the agency is removing its prior recommendation that a biosimilar drug applicant must submit clinical switching studies to demonstrate that a biosimilar is interchangeable with the biologic reference drug. Instead, a biosimilar drug applicant may submit a statement to the FDA explaining why the existing data in a biologic license application would support the FDA’s designation of the drug as interchangeable. Once the FDA designates a biosimilar product as “interchangeable,” pharmacists can substitute that product for a biologic without prescriber intervention.

In its comment, the FTC supports the FDA’s draft guidance, believing it will provide flexibility that may expedite the approval process and reduce the burden and cost of showing that switching a patient from a biologic to a biosimilar is safe and effective. The draft FDA guidance will also help combat marketplace confusion about the safety and efficacy of biosimilars, the FTC’s comment states. If implemented, the guidance would likely reduce barriers to entry and facilitate competition among biologic products by increasing the number of biosimilars designated as interchangeable.