Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018 (see our prior post here), the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020. These recent moves make clear that FDA Commissioner Stephen Hahn, who was confirmed and sworn in to his new role at the tail end of 2019, is continuing to focus agency resources on the Biosimilars and Drug Competition Action Plans developed under the leadership of his predecessor, Dr. Scott Gottlieb.

FDA/FTC Joint Statement and Upcoming Public Workshop on Biosimilar Competition 

Commissioner Hahn reportedly did not discuss the agency’s role in drug pricing during his first all-hands address to FDA on January 30, and there was speculation about how he planned to continue FDA efforts to address high drug prices. But on February 3, FDA and the Federal Trade Commission (FTC) announced a Joint Statement regarding their collaborative efforts to advance competition in the biologic marketplace – and the statement is signed by FTC Chairman Joseph Simons and FDA Commissioner Hahn, putting any such questions to rest.

The five-page Joint Statement provides a brief history of biosimilar products in the U.S. since Congress created the abbreviated pathway for follow-on biologics in 2010 and notes that although FDA has approved 26 biosimilars so far, many of them have not been launched commercially due to “business and intellectual property concerns.” (Check out our recently updated chart of FDA Approved and Pending Biosimilar Applications here for a quick summary of that data.) The Joint Statement also quickly recaps why competition among biologics and biosimilars is desirable and should 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 Joint Statement then outlines that FDA and FTC will be seeking to accomplish four interrelated goals:

1. Coordinate to promote greater competition in biologic markets;

2. Work together to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars;

3. Take appropriate action against false or misleading communications about biologics, including biosimilars, within their respective authorities; and

4. Review (by FTC) patent settlement agreements involving biologics, including biosimilars, for antitrust violations.

FDA’s press release announcing the Joint Statement is available here, and FTC’s press release can be found here.

In addition, the two (increasingly collaborative) enforcement agencies announced that they are convening a joint public workshop to collect input from stakeholders on a “Competitive Marketplace for Biosimilars.” The FDA/FTC workshop is scheduled for March 9, 2020, at FDA’s main campus in White Oak, Maryland. (It will also be webcast.)

The formal meeting notice published in the Federal Register notes:

“FDA and FTC are holding this public workshop to engage with stakeholders about certain aspects of a competitive market for biological products, including biosimilars and interchangeable products, and to discuss the important impact these products have on public health. This includes:

• U.S. Biosimilar Markets and FDA Approval Process;

• Enforcement Activities by FDA and FTC;

• The Benefits of Competition; and

• Improving Stakeholder Engagement: Education and Access.

FDA and FTC also encourage comments from stakeholders and the public relating to steps FDA and FTC can take to facilitate a competitive market for biological products.”

Members of the public can register to attend as well as to make oral presentations during the FDA/FTC workshop; for more information and to secure an in-person spot at the event, keep an eye on the meeting webpage, available here, as FDA’s conference space is typically filled on a first-come, first-served basis.

First FDA Guidance on the Promotion of Biosimilars and Reference Products 

At the same time that the agencies announced their Joint Statement and the FDA/FTC public workshop, FDA published a long-awaited draft guidance for industry entitled, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers.” As the biosimilar marketplace has expanded over the past several years, multiple companies have requested that FDA issue such guidelines to address perceived miscommunications by competitors about what biosimilars are or how they compare to the applicable reference biological products. The February 3 FDA/FTC Joint Statement, as well as the agencies’ public workshop notice, include the following statements about this topic, suggesting that it is a high priority for both agencies and that enforcement actions may follow:

“Both FDA and FTC support competitive markets for biologics and have serious concerns about false or misleading statements and their negative impacts on public health and competition. False or misleading comparisons of reference products and biosimilars may constitute unfair or deceptive practices that undermine confidence in biosimilars. Both agencies want to ensure that health care professionals and patients receive truthful and non-misleading information about biological products. One focus of the agencies is false or misleading communications about biosimilars within their authorities.”

Although FDA’s draft guidance, available here, provides some general guardrails for how to communicate about reference products and biosimilars without running into potentially misleading or false messages, it does not single out specific violations seen in the burgeoning marketplace to date or point to real world examples of misinformation. It also does not discuss considerations unique to promotional materials for interchangeable biosimilars. To date, FDA has not approved any interchangeable products under the 2010 law. However, FDA does include two hypothetical promotional scenarios where it would not expect to take action and one hypothetical that it would view as misleading promotion for an approved biosimilar. 

Comments are being accepted on the FDA draft guidance until April 6, 2020. The docket number and other pertinent administrative information can be found in this Federal Register notice announcing the availability of the draft. Given the importance of promotion and advertising to the development of a robust marketplace for biosimilars and ensuring fair competition among all biological products, we encourage all interested stakeholders to consider submitting feedback on FDA’s first attempt at guidance for industry in this significant area.