On February 3rd, FDA announced several new actions as part of its Biosimilars Action Plan (BAP). If you recall, back in July 2018 when FDA first unveiled the BAP, four key elements were identified: improving efficiency of biosimilar and interchangeable product development; maximizing scientific and regulatory clarity for biosimilar development; developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors; and supporting market competition by reducing gamesmanship or other attempts at unfairly delaying competition. Each of these elements was associated with a number of priority deliverables, and, since then, FDA has been taking steps to meet those (for example, see our prior discussions here and here).
FDA’s most recent actions seek to address the biosimilar market competition element of the BAP. First, FDA and FTC issued a lengthy joint statement that identified four goals to help combat anti-competitive practices in relation to biosimilars: (1) coordinate to promote greater competition in biosimilar markets; (2) work together to deter behavior that impedes access to samples of the reference biological product that are required for testing and development of follow-on products; (3) take actions against false or misleading communications about biologics, including biosimilars; and (4) review patent settlements involving biologics, including biosimilars, for antitrust violations. In particular, the agencies noted their concern with false or misleading statements comparing biological reference products and biosimilars, which may be hampering uptake of biosimilar therapies by creating negative misperceptions about the safety and efficacy of biosimilars. The agencies “intend to take appropriate steps to address companies” who are engaged In such practices.
To further clarify how data and information about biosimilars should be presented in a truthful and non-misleading manner in regulated promotional materials, FDA announced the release of the Draft Guidance for Industry: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers and invited comment by stakeholders in the docket. The draft guidance addresses various considerations, such as identifying reference products and biosimilars in promotional materials, presenting studies that were conducted in support of reference product approval in biosimilar promotional materials, presenting data in promotional material derived from biosimilarity studies that are not part of the biosimilar labeling, and presenting comparisons/comparative claims between reference products and their biosimilar, to name a few.
As part of their efforts to promote greater competition, FDA and FTC also announced that they would be holding a public workshop on March 9 at White Oak, with the goal of bringing together stakeholders from the government, industry, and academia to “discuss FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading communications about biosimilars, and deter anticompetitive behaviors in the biologic product marketplace.” The agencies are inviting written comments and in-person presentations.
And, unlike FTC’s November 2017 workshop on competition in prescription drug markets where FDA was a presenter, the upcoming biologics competition workshop is clearly an effort undertaken by the agencies in collaboration. While FDA and FTC have not always seen eye to eye on all emerging biosimilar issues (such as naming conventions), the statement and workshop make clear their agreement that there will be increasing amounts of promotional activity relative to biosimilars, that such promotional activity could have a chilling affect on the uptake of biosimilars unless it is done in a truthful and non-misleading manner, and that they may be willing to take action sooner rather than later.