The Federal Trade Commission and Food and Drug Administration have signaled they will be increasing their oversight of any potential antitrust behavior in the biologics market, according to a joint statement issued by the U.S. agencies.
In their joint statement published Monday, the FTC and FDA said they will be particularly focused on false or misleading communications regarding biosimilars, drugs that are new to the U.S. market. Unlike generic drugs, which must be chemically identical to their brand counterparts, the FDA requires biosimilar products be “highly similar” to their brand counterparts. According to the FDA, this means biosimilar products cannot have “clinically meaningful” differences in safety, purity, and potency as their brand counterparts.
“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. “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”
“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,” said FDA Commissioner Stephen Hahn.
The FDA and FTC intend to collaborate “to support appropriate adoption of biosimilars, deter false or misleading statements about biosimilars, and deter anticompetitive behaviors in this industry.”
To help in this effort, they’ve announced four goals:
Coordinate to promote greater competition in biologic markets. These efforts will include developing materials to educate consumers and providers about biosimilars and collaborating on future public outreach efforts, including sponsoring a public meeting to discuss competition for biologics.
Collaborate to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars. The FDA and FTC said they will collaborate “to identify and deter tactics used to prevent or impede access to samples of the reference product that the prospective biosimilar applicant needs for testing to be licensed as a biosimilar or interchangeable biosimilar.”
Take appropriate action against false or misleading communications about biologics, including biosimilars. “If a communication makes a false or misleading comparison between a reference product and a biosimilar in a manner that misrepresents the safety or efficacy of biosimilars, deceives consumers, or deters competition, FDA and FTC intend to take appropriate action within their respective authorities,” according to the joint statement. “FDA intends to take appropriate action to address such communications where those communications have the potential to impact public health.” The FDA said it will be publishing draft guidance outlining considerations for FDA-regulated advertisements and promotional labeling that contains information about biologic products.
Review patent settlement agreements involving biologics, including biosimilars, for antitrust violations. The review will include identifying whether these agreements include anticompetitive reverse payment provisions that delay or defeat the introduction of biosimilars. The FTC said it would review such settlements under the same enforcement lens as it uses to evaluate settlements between brand and generic pharmaceuticals.
These efforts in mind, prudent compliance officers of biologics manufacturers should evaluate current business practices regarding any potential anticompetitive behavior in the biosimilar market pertaining to regulatory processes, communications, and patent settlement agreements.