FTC Submits Comment Supporting Proposed FDA Guidance on Interchangeable Biosimilar Drugs

Biologic treatments for medical conditions are becoming increasingly prevalent. According to the Food and Drug Administration (FDA), they are the fastest-growing class of medications in the United States, accounting for a substantial and growing portion of health care costs. Because of this demand, a current proposal by the FDA to simplify the approval process for “biosimilar” versions of biologic products recently received the support of the Federal Trade Commission (FTC), which hopes to promote more competition among these products. Biologics include treatments composed of complex molecules such as sugars, proteins, or nucleic acids, or combinations of these substances, or may be living entities such as cells and tissues. Biologics may be the most effective treatments for a variety of medical illnesses. In some cases, biologics may be the only treatment for conditions that presently have no other treatments available. Because of their cutting-edge nature and the higher costs of being manufactured by biotechnology, biologic treatments tend to be expensive.

Lowering the cost of prescription medications is a highly complex issue. In 2010, Congress enacted the Biologic Price Competition and Innovation Act of 2009 (“BPCIA”). One goal of the act was to lower the costs of biologics by providing for biosimilars to reference biologic products that could foster competition among biological treatments, as generic drugs do for conventional drugs. Obtaining approval from the FDA for a biosimilar is not a small task. The number of biosimilars approved by the FDA remains low, and the costs of biologics remain high. Further, the BPCIA distinguishes between biosimilar products and biosimilar products that are “interchangeable” with the corresponding reference biologic product. If a biosimilar is designated by the FDA as interchangeable, pharmacists can substitute a biologic without intervention of the health care provider who prescribed the reference product, thus expanding the market for the interchangeable biosimilar. To date, however, only a handful of the biosimilar products approved by the FDA have been designated as interchangeable.

In order to promote uptake for biosimilars, the FDA provided Draft Guidance for comment in June 2024, proposing to revise the agency's prior Interchangeability Guidance, to make it easier to show that a biosimilar is interchangeable. In particular, the Draft Guidance removes the recommendation that a biosimilar applicant submit switching studies to demonstrate interchangeability. In clinical switching studies, patients are treated with an alternating regime of the reference product and the biosimilar to show that there would be no difference than if the reference product treatment remained constant. These switching studies can be time-consuming and expensive. In the Draft Guidance, the FDA no longer recommends switching studies and instead allows that applicants may choose to provide an assessment of why the comparative analytical and clinical data provided support a showing of interchangeability. The FDA states that since the publication of the Interchangeability Guidance, the agency has gained further experience in evaluating biosimilar products, as well as pointing to currently available analytical technologies.  

The Federal Trade Commission exercises primary responsibility for federal antitrust enforcement in the pharmaceutical industry. On August 20, 2024, the FTC issued a comment in support of the FDA Draft Guidance. The commission stated that it believes the FDA’s revised guidance on interchangeability would simplify the approval process and reduce the burden and associated cost of showing that a biosimilar is safe and effective. This in turn could lower barriers to entry and foster increased competition in biologic marketplaces, increase patient access to biosimilars, and lower health care costs for patients.