A press release from the US Food and Drug Administration and the Federal Trade Commission announced the signing of a joint statement that focuses on anticompetitive behavior in the biosimilar market. According to the FDA and FTC, this statement describes “key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anticompetitive behavior in this space.”
When introducing the Biosimilar Action Plan in 2018, former FDA Commissioner Scott Gottlieb noted that biosimilar market competition is being hampered by reference manufacturers’ attempts to unfairly delay competition. “Strengthening the partnership and interagency coordination between FDA and FTC will help each agency address and deter anticompetitive behavior in the US market for biological products,” stated the federal agencies today. “Such behavior might include anticompetitive reverse payment agreements, abusive repetitive regulatory filings, or misuse of restricted drug distribution programs.”
In the press announcement, FDA Commissioner Stephen M. Hahn remarked, “Strengthening efforts to curtail and discourage anticompetitive 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 added, “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”
The FDA and FTC have pledged to begin efforts in 4 areas:
- They will coordinate to promote greater competition in biologic markets.
- They 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. FDA is publishing a draft guidance outlining considerations for FDA-regulated advertisements and promotional labeling that contains information about biologic products.
- FTC will review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.
A Real Beginning for the Biosimilar Action Plan?
It is unclear what action(s) will arise from this joint statement. Although a few initiatives have been implemented, such as limiting the ability of Citizens Petitions to delay FDA decision making on biosimilar applications, both the FDA and FTC have not addressed other opportunities to attack anticompetitive behavior in this marketplace.
Legislation, such as the CREATES Act (first introduced in 2017 and is awaiting action in 2020), was intended to address the ability of prospective biosimilar makers to obtain biologic samples from reference manufacturers. It is unclear what teeth FDA or FTC will use to take a bite out of these delaying tactics.
In 2019, the Trump administration backed away from the removal of the drug rebate safe harbor, believing that it might somehow result in higher Medicare premiums. Pfizer’s 2017 lawsuit against Janssen Biotech seeks to address the use of exclusionary rebate contracts. No other significant actions against drug rebates have been taken to date.
The FDA has unintentionally encouraging misinformation by requiring the use of four-letter suffixes for the biosimilars but not their reference products. Interestingly, the FTC disagreed with this policy, and submitted comments to the FDA explaining why it believes this will contribute to misinformation.
The FTC has been opposed to “pay for delay” deals, which have principally been seen in the generic marketplace. Legislators have tried to move proposals through Congress or the Senate that prevent these arrangements, but these have not progressed very far. In the biosimilar arena, licensing arrangements that pay royalties to the reference manufacturer and allow biosimilar firms to start marketing their product after a certain date may not exactly fit this “pay-for-delay” description. Further, some argue that these arrangements may actually create an avenue for earlier access to the less-expensive biosimilar.
Importantly, the FTC has not yet taken any material action to address the anticompetitive patent thickets that prevent marketing of biosimilars for some of oldest biologic agents.
Is this statement by the FTC and FDA a first step in activating the Biosimilar Action Plan? Or is it a first step towards a collaboration that leads to a beginning?
