Last week, the FDA and Federal Trade Commission (FTC) released a joint statement promoting collaboration to improve the marketplace for biological products, highlighting the necessity of incorporating biosimilars and interchangeable products and deterring anti-competitive behavior. Biological products are defined by FDA as “a diverse category of products…may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs.”
In the announcement, FTC Chairman Joseph Simons expounded that “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”. FDA Commissioner Stephen M. Hahn, M.D. noted that “Competition is key for helping American patients have access to affordable medicines…biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs”. The FDA and FTC believe that the misleading information being presented to the public when comparing biologic reference products to “biosimilars” is preventing the patients from accessing these products due to cost.
Biosimilars are biological products that are shown through comparative tests to be “highly similar” to FDA-approved biological products, with only minor structural differences, and demonstrate no meaningful difference in terms of safety and efficacy. Typically in the U.S., biosimilar products market cost is 15-35% lower than the reference product. The FDA and FTC think that the current anti-competitive practices are slowing progress and are concerned with the negative impact of these practices on the public perception of the safety and efficacy of these biosimilar products.
The joint statement outlined the following joint goals of the two agencies, which include:
- Collaborate to promote greater competition in biologic markets
- Work together to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars.
- Take appropriate action against false or misleading communications about biologics, including biosimilars, within their respective authorities.
Additionally, the FTA plans to review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.
This announcement is part of the FDA’s continued efforts to encourage biologics innovation and affordability through the promotion of a competitive market. The implementation of the Biologics Price Competition and Innovation Act (BPCI Act) in 2009 allowed for the FDA to approve the use of products deemed to be biosimilar or interchangeable to an already approved (reference) biological product; however, the FDA was unable to approve the biosimilar or interchangeable product until 12 years after the original biologic was licensed. Due to these constraints, the FDA took several steps to continue scientific and regulatory policy advancement, finally releasing the Biosimilars Action Plan (BAP) in July of 2018.
The new draft guidance published by the FDA in February 2020 addresses their current views on how to relay information about biosimilars in response to one of the key actions outlined in the BAP.
The FDA has opened this draft guidance up for comments through 06 April 2020. The FDA and FTC also announced a public workshop on March 9th to discuss the FDA and FTC’s collaborative efforts to support biosimilars acceptance, discourage anticompetitive practices and deter misleading statements in the biologics market in relation to biosimilars. The workshop does have a Webcast option and has opened the floor for individuals to voice their opinions.
What are your thoughts on the current plans to promote competition in the biological marketplace and discourage misleading statements in relation to biosimilars?Barry Callebaut @ ISM_2020 via photopin (license)