Injecting competition into biologics: the US agencies’ plan of action
A Boon for biologics Competition
The Federal Trade Commission continues to focus on conduct relating to competition and market access in the biologics space, mirroring its actions with respect to small-molecule pharmaceuticals. Biologics are some of the most important injectable drugs today, targeting conditions ranging from arthritis to cancer. The agency’s remedy policy already recognizes that getting biologics to market can be more challenging than for small-molecule pharmaceuticals. We expect the FTC’s focus on removing entry obstacles will only sharpen as biologics increase in medical and economic importance.
Central to their initiatives is a joint FTC/FDA (Food and Drug Administration) statement announced on February 3, 2020. We’ve summarized the agencies’ four goals below, with a focus on the FTC:
- The agencies will coordinate to promote greater competition in biologics markets, including collaboration on public outreach efforts. The agencies have scheduled a March 9, 2020 workshop to discuss competition for biologics.
- The agencies will work together to deter behavior impeding access to samples needed for biologics development, including biosimilars. The agencies will also assess the usefulness of additional information sharing arrangements.
- The agencies intend to act against false or misleading communications about biologics, including biosimilars, within their respective authorities. The FTC will address unfair or deceptive acts or practices not subject to FDA jurisdiction, with a focus on false or misleading comparisons between reference products and biosimilars that misrepresent the safety or efficacy of biosimilars, deceive consumers, or deter competition.
- The FTC will review patent settlement agreements involving biologics, including biosimilars, for antitrust violations. As with patent settlement agreements between brand and generic drug manufacturers, the FTC will review patent settlement agreements between reference products and biosimilar manufacturers to evaluate whether these agreements include, for example, anticompetitive reverse payments that slow or defeat entry.
For the FTC, this announcement is another example of its ongoing activity in the biologics/biosimilars space. In 2019, for instance, the FTC submitted a comment to the FDA reiterating concerns about potential naming conventions that distinguish certain subsets of entrants. The FTC argued that the proposed scheme “likely would create consumer confusion and discourage use of newly introduced biosimilar and interchangeable products …[and] thus diminish future competition.”
Over the last several years, political focus on the high cost of medical drugs has motivated these US antitrust agencies to increase their focus on the pharmaceutical sector. This trend is likely to continue, as antitrust – and its role in the economy – continues to move to the forefront of the US national debate.