FTC Submits Comment Supporting Proposed FDA Guidance on Interchangeable Biosimilar Drugs

The Federal Trade Commission submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs that can be substituted for brand-name biologic products, stating that the FDA’s guidance would increase patient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.

Biologic drugs—which are composed of very large, complex molecules—treat serious medical conditions and are often one of the most expensive types of prescription medications. A biosimilar drug is like 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Under the FDA draft guidance, the FDA is removing its prior recommendation that a biosimilar drug applicant must submit clinical switching studies to demonstrate that a biosimilar is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In its comment, the FTC supports FDA’s draft guidance, believing it will provide flexibility that may expedite the approval process and reduce the burden and cost of showing that switching a patient from a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.

According to the FTC, 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 (BPCIA) 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.

To ensure Americans receive increased access to interchangeable biosimilars, agencies must continue to monitor anticompetitive practices that, if left unchecked, could prevent patients from accessing biosimilars, the comment states. Contract terms that discourage generic drug insurance reimbursement, as revealed in the Commission’s Interim Staff Report on Pharmacy Benefit Managers, undermine goals of the BPCIA to increase competition and innovation among biologics, the comment states.

The Commission voted 5-0 to submit the comment to the FDA.