FTC Supports FDA’s Simplified Biosimilar Interchangeability Plan

Simplified Interchangeability Process:
The FDA has proposed a draft guidance to simplify the process for biosimilar drugs to be designated as interchangeable, which would allow pharmacists to substitute them for brand-name biologics without prescriber intervention.

FTC Endorsement:
The Federal Trade Commission (FTC) has endorsed the FDA's plan, stating it will increase patient access to lower-cost prescription medications and combat marketplace confusion about biosimilars.

Removal of Clinical Switching Studies:
The FDA's draft guidance removes the requirement for biosimilar drug applicants to submit clinical switching studies, instead allowing them to provide a rationale supported by existing data to demonstrate interchangeability.

Increased Competition:
The FTC believes the guidance will reduce barriers to entry and facilitate competition among biologic products, potentially leading to lower prices and increased choices for patients.

Monitoring Anticompetitive Practices:
The FTC emphasizes the need to monitor anticompetitive practices that could prevent patients from accessing biosimilars, such as contract terms that discourage generic drug insurance reimbursement.