Earlier this month, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) released a joint statement about biosimilar marketing. The joint statement notes both agencies plan to have a continued focus on supporting the adoption of biosimilars, deterring false or misleading statements about biosimilars, and deterring anticompetitive behaviors in the industry.
The statement was made in furtherance of the Biosimilars Action Plan of July 2018 and makes clear that current FDA Commissioner Stephen Hahn, MD, plans to continue to focus agency resources on the Biosimilars and Drug Competition Action Plans developed under former Commissioner Dr. Scott Gottlieb.
The Joint Statement discusses the brief history of biosimilar products in the United States, beginning in 2010 when Congress created the abbreviated pathway for follow-on biologics. The statement notes that while the FDA has approved 26 biosimilars, most of them have not seen a commercial launch due to “business and intellectual property concerns.”
The Joint Statement also references why competition among biologics and biosimilars is important and why it is expected to generate “significant price competition and consumer savings.” The agencies explain that strengthening their partnership and coordinating their efforts in this area “will help each agency address and deter anticompetitive behavior in the U.S. market for biological products…[which] might include anticompetitive reverse payment agreements, abusive regulatory filings, or misuse of restricted drug distribution practices.”
The FDA and FTC are currently trying to accomplish four interrelated goals, each discussed in greater detail below:
- Coordinate to promote greater competition in biologic markets;
- Work together to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars;
- Take appropriate action against false or misleading communications about biologics, including biosimilars, within their respective authorities; and
- Review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.
Promoting Greater Competition
On the first goal, the FDA and FTC coordinating to promote greater competition in biologic markets, the agencies acknowledge that more robust competition can actually help to reduce the costs of biologics and help facilitate increased patient access to important therapies. To that end, the agencies will cooperate in efforts to facilitate biologics competition to the extent possible. The FDA will also develop materials to educate consumers and providers about biosimilars, and both agencies will collaborate on future public outreach efforts, including sponsoring a public meeting to discuss competition for biologics.
Deterring Behavior That Impedes Access to Samples
On this point, the agencies plan to work together to identify and deter tactics that are being 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. In order to facilitate that collaboration, the agencies will evaluate whether additional information sharing arrangements are warranted.
Taking Action Against False or Misleading Communications
The agencies expect to work together, as authorized by their respective statutes, to address false or misleading communications about biologics, including biosimilars. Specifically, 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, the agencies will take appropriate action within their authorities. The FDA plans to take action to address any communications that have the potential to impact public health.
The FDA also plans to use its authority under the Food, Drug, and Cosmetic Act (FD&C Act) to address false or misleading communications under its jurisdiction. The FTC, on the other hand, expects to use its authority to address unfair or deceptive acts or practices outside the FDA’s jurisdiction.
Additionally, the FDA is publishing a draft guidance outlining considerations for FDA-regulated advertisements and promotional labeling that contains information about biologic products.
Reviewing Patent Settlement Agreements for Antitrust Violations
The FTC will use its authority pursuant to the Patient Right to Know Drug Prices Act, under which it obtains and reviews settlement agreements between reference product and biosimilar manufacturers. This helps the FTC to evaluate whether the agreements include – among other things – anticompetitive reverse payments that either slow or entirely defeat the introduction of lower-priced medicines, including biosimilars.
Agency Comments on the Joint Statement
In releasing the joint statement, FDA Commissioner Hahn noted that, “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. Commissioner Hahn continued, “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.”
FTC Chairman Joseph Simons also acknowledged the important of biologics, stating, “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,” Chairman Simons said. “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”
Upcoming Public Workshop
The two agencies also announced an upcoming live and webcast joint public workshop focused on collecting input from stakeholders on a “Competitive Marketplace for Biosimilars” set for March 9, 2020 at the FDA’s White Oak, Maryland campus. If wish to submit comments, instructions on how to do so are here. All comments must be submitted on or before April 9, 2020.