AHIP Submits Policy Recommendations To FDA And FTC On Supporting A Competitive Biosimilars Marketplace

posted by AHIP

on April 9, 2020

Earlier today, AHIP submitted a comment letter to the FDA and FTC detailing policy recommendations and other actions for supporting a competitive marketplace for biosimilars.  The comments are in response to a FDA/FTC joint public workshop—held last month—that featured input from stakeholders and outside experts on how to improve access to biosimilars and address barriers to competition.

Our draft comments strongly support FDA/FTC collaborative efforts to support adoption of biosimilars, discourage false or misleading information, and deter anti-competitive behaviors in the biologic/biosimilar marketplace.  The letter also offers comments and policy recommendations to FDA/FTC—consistent with our public policy positioning and principles—to facilitate a competitive marketplace for biosimilars.  The main recommendations include the following—

  • Continue and accelerate efforts to streamline the FDA approval process, and issue guidance necessary to promote regulatory clarity in the biosimilars marketplace;
  • Address false and misleading information disseminated by brand-name, reference-product drug makers that sows doubt and confusion about the safety and efficacy of biosimilars;
  • Develop effective communication tools and strategies to educate physicians, hospitals, patients and other stakeholders to raise awareness about the safety and efficacy of biosimilars;
  • Use existing enforcement tools and authorities to thwart anti-competitive behaviors and close loopholes that delay or prevent biosimilar competition; and
  • Pursue additional public policies—at the federal and state level—to promote greater availability of and access to biosimilars and interchangeable products.