The U.S. Food and Drug Administration and the Federal Trade Commission today released a joint statement regarding collaboration to advance competition in the market for biologic products. According to the FDA press release, “[t]his joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.”
The Statement identifies four joint goals to help in this effort:
- FDA and FTC will coordinate to promote greater competition in biologic markets.
- FDA and FTC will work together to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars.
- FDA and FTC intend to take appropriate action against false or misleading communications about biologics, including biosimilars, within their respective authorities.
- FTC will review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.
The FDA and FTC also will be holding a public workshop, “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars” on March 9 at the FDA’s White Oak Campus in Silver Spring, Maryland.
