FDA Announces Several Actions to Facilitative a Competitive Marketplace for Biological Products

Today, the Food and Drug Administration (FDA) is announcing several actions as part of the agency’s overall efforts to facilitate increased access to biological products, and to fulfil deliverables outlined in the Biosimilars Action Plan. The FDA and Federal Trade Commission (FTC) have released a Joint Statement that outlines shared goals and objectives and details how FDA and FTC will work together to promote competitive markets for biological products. The four goals the Agencies expand on in the statement are:

1. FDA and FTC will coordinate to promote greater competition in biologic markets.
2. FDA and FTC will work together to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars.
3. FDA and FTC intend to take appropriate action against false or misleading communications about biologics, including biosimilars, within their respective authorities.
4. FTC will review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.

FDA is also announcing a Food and Drug Administration/Federal Trade Commission Workshop on a Competitive Marketplace for Biosimilars. The purpose of the public workshop is to discuss FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading communications about biosimilars, and deter anticompetitive behaviors in the biologic product marketplace.

Finally, FDA is releasing a Draft Guidance for Industry: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers. The guidance discusses considerations for presenting data and information about reference or biosimilar products in FDA-regulated promotional materials to help ensure they are truthful and non-misleading as required under the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations.   

FDA has and will continue to play a critical role in facilitating increased access to biosimilars, by supporting robust and timely competition, which can help increase patient access and reduce cost burdens on patients and our health care system. In addition, FDA wants to help ensure the United States remains a driving force in medical innovation, and part of that role includes helping to ensure communication of truthful, non-misleading, and balanced information about biological products, by drug manufacturers, packers and distributors and those acting on their behalf. 

For more information, and to comment on the draft guidance, please see the Notice of Availability. To submit comments regarding the public workshop, please see the Federal Register Notice.