Congress recently passed two bills that are designed to educate patients and prescribers about biosimilars and thereby encourage their use and to close a loophole in existing law that allows certain branded drugs to retain longer market exclusivity. That loophole currently blocks generic market entrants for longer periods of time. Both laws are headed to President Biden for signature.
The first law, the “Advancing Education on Biosimilars Act of 2021”, contains both mandatory and permissive requirements to be followed by the Secretary of Health and Human Services (HHS) that would foster wider use and prescribing of biosimilars. First, HHS is granted the specific permissive authority to create and maintain “an internet website to provide educational materials for health care providers, patients, and caregivers regarding the meaning of the terms, and the standards for review and licensing of, biological products, including biosimilar biological products and interchangeable biosimilar biological products.” The intent of this portion of the law is to explain to the public, as well as prescribers, the unique features of biological, biosimilar biological, and interchangeable biosimilar biologics – all of which can be intimidating and technical concepts to the average patient. The law also requires the Secretary to develop or improve continuing education programs targeted towards health care providers “that advance the education of such providers on the prescribing of, and relevant clinical considerations with respect to, biological products, including biosimilar biological products and interchangeable biosimilar biological products,” obviously to further encourage providers to prescribe these therapies.
The other law, the “Ensuring Innovation Act”, amends portions of the Federal Food, Drug, and Cosmetic Act (FDCA) that govern review and approval of new drugs and the exclusivity periods that accompany the same. Specifically, the law revises Section 505 of the FDCA to require that approval of a drug’s “active moiety” – as opposed to the current standard of “active ingredient” – be the standard upon which statutory exclusivity must be based. Supporters of the law have praised the more specific language, which is designed to limit pharmaceutical manufacturers from obtaining exclusivity periods for products without truly meaningful or new chemical changes or differences like certain perceived line extension products. Congress has made these changes in an effort to further allow for more and faster generic competition with the end goal of lowering costs to both patients and Federal health care programs.