The presidential administration may have changed, but the legislative branch remains focused on issues relating to patient access to drugs. One of these efforts includes P.L. 117-8, the Advancing Education on Biosimilars Act of 2021. Formerly S.164, it was introduced in the Senate in February 2021 and sped through the House to enactment on April 23, less than three months later.

P.L. 117-8: Aimed at increasing biosimilar uptake 

P.L. 117-8 is intended to educate health care providers and the public about biological drug products (reference biologics and biosimilars). Perhaps unsurprisingly, however, the ultimate aim of this Act relates to these drugs’ prices. In introducing an earlier version of this Act (S. 1681), its sponsors noted that its purpose was to promote the use of cheaper biosimilars, observing that “[l]ess than two percent of Americans use biologics, but they make up 40 percent of total spending on prescription drugs.”

Indeed, commentators have noted that physicians’ willingness to prescribe biosimilars has been hampered by various barriers including limited understanding or confusion about these drugs. According to the Act’s sponsors, the educational materials created pursuant to P.L. 117-8 would improve physician confidence in biosimilars’ safety and effectiveness, leading to their increased use and increased cost savings.

To this end, P.L. 117-8 requires the Department of Health & Human Services to advance “education and awareness” regarding biologic products. The agency’s efforts may entail the creation or improvement of continuing education programs that teach providers about “the prescribing of, and relevant clinical considerations” for these drugs, “as appropriate.” In particular, P.L. 117-8 contemplates the creation of a comprehensive suite of educational materials that could serve as a trusted one-stop shop for information about biologics.

Amending 42 U.S.C. § 262, the Act permits the Department of Health & Human Services to maintain a website to provide materials concerning biologics to health care providers, patients, and their caregivers. These materials include:

  • Explanations of key statutory and regulatory terms (e.g., “interchangeable” and “biosimilar”) and clarifications regarding the use of interchangeable biologics;
  • Development programs for biologic products, which may relate to the “comparability” of biologics and biosimilars;
  • An explanation of the process for reporting adverse events for biologics; and
  • An explanation of the relationship between biosimilar and interchangeable products and their reference products, including standards for review and licensing of each product.

Will P.L. 117-8 meaningfully impact biosimilar acceptance?

It is not clear what value P.L. 117-8 will add over resources concerning biosimilars which presently exist.

Over the past several years, beginning with the efforts of former Commissioner Gottlieb in 2017 to improve biosimilar access, the FDA has made various educational materials available to practitioners and the interested public.

Currently, for example, the FDA’s website hosts a portal with links to information on Biosimilars. These links direct interested persons to information, fact sheets, webinars, and other materials which have been have been available for years.  These include:

In light of the resources that are already available to healthcare providers and the public, it remains to be seen whether P.L. 117-8’s provisions will lead to meaningful differences.

The Act presents an opportunity for the FDA to reconsider its materials, however, and consider the interests and concerns of various stakeholders. We will continue to monitor and report on developments in this area.

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Photo of Siegmund Y. Gutman Siegmund Y. Gutman

Siegmund (“Sige”) Gutman is chair of the Life Sciences Patent Practice, a partner in the Litigation Department, and a member of the Patent Law and Intellectual Property Groups.

Sige is an accomplished patent litigator, frequently representing clients before trial and appellate courts, as…

Siegmund (“Sige”) Gutman is chair of the Life Sciences Patent Practice, a partner in the Litigation Department, and a member of the Patent Law and Intellectual Property Groups.

Sige is an accomplished patent litigator, frequently representing clients before trial and appellate courts, as well as arbitration panels. In the life sciences area, his practice focuses on developing and executing market exclusivity and freedom-to-operate strategies, including patent office and FDA regulatory strategies, for leading biologics, pharmaceutical, biotechnology, and medical device clients. He has extensive experience successfully litigating biologic drug patent and Hatch-Waxman cases, and has frequently spoken and written about issues relating to biosimilars and generic drugs. Sige’s background combines a graduate degree in molecular and cell biology and biophysical chemistry with more than 20 years of industry experience, including serving as senior patent litigation counsel for Amgen, the world’s largest biotechnology company.

He advises clients on patent matters involving a wide range of technologies, including therapeutic proteins such as monoclonal antibodies, antibody-drug conjugates, nucleic acids, gene therapy, stem cells, expression systems, screening methodologies, purification processes, DNA microarrays, small molecules and polymer chemistry.

Sige also has extensive experience in inter-partes patent office actions, including oppositions, and providing strategic patent counseling, including addressing product life cycle management and patent portfolio development issues, as well as preparing third-party patent landscape analyses.

Prior to joining Proskauer, Sige was a partner at another Am Law 100 firm.

While in graduate school, Sige worked on elucidating the 3-D structure of an auto-catalytic RNA using molecular biological, biochemical and biophysical techniques. He also previously worked for a major manufacturer of photocopiers and printers, where he helped develop novel color toner particles using electrochemical, photochemical and polymer chemical techniques.