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Recent Developments in Government Protection of Biosimilar Competition

In February, the U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) published a joint statement regarding collaborative efforts to promote competition in the marketplace for biological products – including biosimilars and interchangeable products – by identifying joint goals both agencies will work to achieve, as well as measures to be taken to achieve those goals.   While the joint statement reiterated the importance of promoting competition in the biologics market to benefit consumers and innovation, it also addressed the need to take action to discourage false or misleading statements and promotional communications by biological product manufacturers.  The statement discussed the utility and benefits of biologics; and identified some of the federal government’s actions to develop a competitive biologics industry, starting with the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) and ending with the FDA’s 2018 Biosimilars Action Plan (“BAP”), which outlined strategies to accelerate biosimilar competition.   As one of the goals mentioned in the BAP was to support market competition by reducing “gaming” and other methods to unfairly delay biosimilar competition, the recent joint statement appears to be the next step towards achieving that goal.

The joint statement identified four “joint goals” to help the effort to deter false or misleading statements about biosimilars and other anticompetitive behaviors in the industry.  First, the agencies will coordinate to promote greater competition in biologic markets to the extent possible.  This goal will be achieved by the FDA developing materials to educate consumers and providers about biosimilars, and both agencies collaborating on future public outreach efforts, such as sponsoring a public meeting to discuss competition for biologics.  The second goal identified is that the FDA and FTC will work together to deter behavior that impedes access to samples needed for the development of biologics.  To this end, both agencies will collaborate to identify and deter tactics used to prevent or impede access to samples of the reference product that a prospective biosimilar applicant needs for testing in order to be licensed as a biosimilar or interchangeable biosimilar, as well as consider additional information sharing arrangements between each other.  The third goal is to take the appropriate action against false or misleading communications about biologics, including biosimilars within their respective authorities.  The joint statement expressed both agencies’ intent to use their statutory authority to the fullest extent to take action against communications that misrepresent the safety or efficacy of biosimilars, deceives consumers, deters competition, or have the potential to impact public health.  The FDA also stated its plans to publish draft guidance outlining considerations for FDA-regulated advertisements and promotional labeling that contains information about biologic products.  It has since published that guidance, in which it discusses its position on topics such as the general content requirements for FDA-regulated promotional materials for reference products and biosimilar products, how to identify reference products and biosimilar products in such materials, what firms should consider before presenting data or information from the studies conducted to support licensure of the reference product, and what to consider when comparing reference products and biosimilar products.  As a final goal, the FTC will review patent settlement agreements involving biologics, including biosimilars, for antitrust violations, pursuant to its authority via the Patient Right to Know Drug Prices Act.

In addition to the agencies’ efforts, a number of pending legislation hope to address the biosimilar market.  The Purple Book Continuity Act (HR1520) would require the publication of patents disclosed during the BPCIA patent dance, the legislative process to get biosimilars approved to market.  The Affordable Prescriptions for Patients Act of 2019 (S 1416) and Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 (HR 3991) aim to diminish anticompetitive behavior during the patent dance by prohibiting the act of “product hopping” by reference product owners, and limiting the number of late-filed or late-issued patents that could be asserted during the dance, respectively.  The first two have reached the Senate, and the third is still in the reporting phase.

These actions clearly illustrate the federal government’s intent to improve the current condition of the biosimilars market.  Time will determine, however, whether their actions are as strong as their intentions.