Drugs

FDA, FTC Biosimilar Workshop Summary Out

FDA and the Federal Trade Commission (FTC) have released a summary of their 3/9/2020 joint workshop on a competitive marketplace for biosimilars. The document says the workshop’s purpose was to “discuss FDA’s and FTC’s collaborative efforts to support appropriate adoption of biosimilar products, discourage false or misleading communications about biosimilar products, and deter anticompetitive conduct in the biological product marketplace.”

The summary references the 7/2018 FDA Biosimilars Action Plan that focused on:

improving the efficiency of the biosimilar and interchangeable product development and approval process;
maximizing scientific and regulatory clarity for the biosimilar product development community;
developing effective communications to improve understanding of biosimilars among patients, clinicians, and payers; and
supporting market competition by reducing gaming of FDA requirements and other attempts to unfairly delay competition.

A month before the workshop, the two agencies issued a joint statement regarding a collaboration to advance competition in the biologic marketplace.

The summary reviews the workshop’s six panel discussions:

the FDA licensure process and the U.S. biosimilar market;
FDA and FTC approaches to ensure truthful and non-misleading advertising and promotional communications;
an FDA draft guidance on promotional labeling and advertising considerations for prescription biological reference and biosimilar products;
the benefits of competition;
education and understanding to improve stakeholder engagement; and
biosimilar disparagement as an antitrust or consumer protection cause of action.

It also reports on the public comments made at the workshop.

The summary concludes that the workshop “highlighted serious concerns about false or misleading communications regarding reference, biosimilar, and interchangeable products, and the potential for such communications to negatively affect public health, patient access, and competition….. Educational resources directed to consumers, patients, and healthcare providers, among others, were identified as a key means to help counter false or misleading communications.”

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