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The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.
Biological products are a diverse category of products which may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are used to diagnose, prevent, treat, and cure diseases and medical conditions. Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from existing FDA-approved “reference” products. Reference products are FDA-approved biological products against which proposed biosimilar products are compared.
Biosimilars marketed in the U.S. typically have launched with initial list prices 15 to 35% lower than comparative list prices of the reference products.
The FDA and the FTC have serious concerns about such statements and their negative impact on public health, including their potential to create negative misperceptions about the safety or effectiveness of approved biosimilars. The agencies intend to take appropriate steps to address companies making false or misleading communications about biologics, including biosimilars and interchangeable products, which will help deter anti-competitive behavior in the biologics market and can help lead to the use of all available biological products.
The agencies will exchange information, when appropriate, about best practices to prevent activities that impede access to samples of the reference product that the prospective biosimilar applicant needs for testing. Additionally, the FTC intends to review patent settlement agreements involving biosimilars, to prevent antitrust violations.
Another key to ensuring that public information surrounding biosimilars and their reference products is communicated in a truthful and non-misleading manner is the FDA’s regulation of industry’s promotional materials for all prescription drugs, including biosimilar and reference products. Therefore, the FDA is publishing a draft guidance outlining its current thinking on
Availability of this new draft guidance and ongoing collaboration with the FTC is part of the FDA’s continuing work to help ensure truthful and non-misleading prescription drug promotion and serves as another example of the FDA’s commitment to public health by addressing anti-competitive tactics that aim to undermine confidence in the safety and effectiveness of FDA-approved biosimilar products.
Today’s announcements are key deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products. The FDA is accepting comments from the public on the draft guidance from Feb. 4 to April 6.
