FDA and FTC Collaborate on Competitive Biologics Market

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The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.

On Feb. 3, 2020, FDA announced that it is working with the Federal Trade Commission in a joint effort to ensure a robust marketplace of biological products. The agencies will work to deter anti-competitive behavior in the biosimilars market.

Biosimilars of FDA-approved reference products may reduce healthcare costs, according to FDA, and the agency has been taking steps to promote the growth of the biosimilars market. “Biosimilars marketed in the US typically have launched with initial list prices 15 to 35% lower than comparative list prices of the reference products,” the agency stated in a press release.

The industry, however, has seen some pharmaceutical manufacturers of reference products participate in anti-competitive behavior. This behavior may include making false or misleading statements about biosimilars, which may could have a negative impact on the perception of the efficacy and quality of approved biosimilars.

FDA and FTC will be collaborating on public outreach efforts to bring industry, academia, and government agencies together to discuss competition in the biosimilars market. The agencies will discuss best practices for preventing anti-competitive behavior, and FTC will review patent settlement agreements that involve biosimilars.

FDA is publishing guidance on the presentation of data and information about biosimilars and reference products in FDA-regulated promotional materials. The guidance will answer questions about the development of promotional materials and provide examples of situations involving the promotion of biosimilars and reference products.


“Competition is key for helping American patients have access to affordable medicines. 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” said FDA Commissioner Stephen M. Hahn, MD, in a press release. “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. 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,” said FTC Chairman Joseph Simons, in the release. “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”

Source: FDA