The FDA and U.S. Federal Trade Commission (FTC) announced today that they signed a joint statement to encourage collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products.
The two agencies said the statement sets out to address false or misleading promotion about biosimilars within the respective authorities and to deter anticompetitive behavior in the space as well.
Biosimilars are biological products that are highly similar to and have no clinically meaning differences from existing FDA-approved “reference” products, according to the joint statement. The FDA and FTC believe biosimilars have the potential to reduce health care costs, as biosimilar products marketed in the U.S. typically launch with initial list prices between 15% and 35% lower than comparative list prices of the reference products.
The FDA and FTC believe anticompetitive practices may slow the progress of biosimilars. Those practices may include making false or misleading claims when comparing biological reference products and biosimilars. The agencies plan to address companies making those claims in an effort to encourage the use of all available biological products.
Both agencies also plan to collaborate on public outreach efforts, which will include a public workshop discussing the matter on March 9 at the FDA’s White Oak Campus in Silver Spring, Md. The FDA and FTC want to explore the best practices to prevent anticompetitive activities, while the FTC said it also plans to review patent settlement agreements involving biosimilars to prevent antitrust violations.
The FDA said it is publishing a draft guidance to share its thinking on presenting data in a truthful and non-misleading way regarding biosimilars and reference products in FDA-regulated promotion materials.
“Competition is key for helping American patients have access to affordable medicines,” FDA commissioner Dr. Stephen Hahn said in the joint statement. “While these therapies are critical for patients, biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs. Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”
“Biologics are essential to the treatment of many serious illnesses,” added FTC chairman Joseph Simons. “Practices in biologics markets are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation. The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”