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.
“Competition is key for helping American patients have access to affordable medicines. While these therapies are critical for patients, biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs” said FDA Commissioner Stephen M. Hahn, M.D. “Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”
“Biologics are essential to the treatment of many serious illnesses. Practices in biologics markets are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation,” said FTC Chairman Joseph Simons. “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”
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.
Biosimilar and interchangeable products have the potential to greatly reduce health care costs, similar to what has been seen with increased generic drug offerings. The 1984 Hatch Waxman Act, which created an abbreviated path to market for generic versions of small molecule drugs, has saved patients roughly $2 trillionExternal Link Disclaimer over the past decade. While the U.S. market for biosimilar versions of biological products is still maturing, the FDA’s research suggests that after market entry, biosimilars have the potential to offer significant savings. 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.
However, anti-competitive practices, such as making false or misleading statements comparing biological reference products and biosimilars, may be slowing progress and hampering uptake of these important therapies. 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.
As detailed in the joint statement, the agencies will also collaborate on future public outreach efforts, including bringing together participants from industry, academia and government agencies to discuss issues relating to competition in the biologics market. To this end, today we’re also announcing that the FDA and FTC will hold a public workshop, “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars” on March 9 at the FDA’s White Oak Campus in Silver Spring, Md.
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 presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials. It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.
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.
- Jim McKinney