FDA and FTC Announce Collaboration to Support Biosimilars Market

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:

  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.

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.