Streamlining and Accelerating Biosimilar Adoption in the United States

View PDF

Biologic medicines have brought extraordinary clinical benefits to patients living with difficult conditions such as cancer and autoimmune and ophthalmic diseases. But such therapies are expensive, accounting for about 43% of pharmaceutical spending in the United States (1).

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created a regulatory pathway for a class of biologics called biosimilars, which replicate branded biologic drugs at lower cost (2, 3). The BPCIA was designed to provide greater access to biologics by bringing biosimilars to market, in turn stimulating competition and lowering the overall cost of healthcare.

Biosimilars first became available in the United States in 2015. Since their introduction, uptake patterns have differed across therapeutic areas. For instance, infliximab biosimilars began receiving regulatory approval in 2016, but they are used less frequently than is the reference product. However, in oncology, trastuzumab biosimilars have captured over 80% of the market after their introduction in 2019.

Despite their successes, many biosimilar products struggle to gain traction in the United States for a number of reasons. Healthcare professionals and patients have expressed lingering concerns about biosimilar safety and efficacy. The complexity of the US healthcare system and the marketing practices of reference-biologic manufacturers further complicate widespread adoption.

A Multifaceted Approach To Increase Market Acceptance
Educating healthcare workers, pharmacists, and other institutional stakeholders will help reduce barriers to biosimilar adoption. Stakeholders need to understand the process undertaken by the US Food and Drug Administration (FDA) for approving biosimilars and how switching to such fully interchangeable products offers full treatment continuity for patients. Stakeholders also should learn about the history of biosimilar use in Europe and the financial value that biosimilars can have for individual providers, hospitals, payers, and patients.

Successfully educating stakeholders about biosimilars requires effort at many levels. Medical-meeting organizers can improve education by hosting panels, presentations, and continuing-education programs that are sponsored by biotechnology companies and endorsed by professional medical societies. Professional societies and government agencies should include biosimilar information among the clinical guidelines that they issue for treatment protocols. Curricula for medical-school programs should include sessions about biosimilars. Perhaps most important for clinicians and pharmacists is to include peer-to-peer learning about lived experiences and best practices for using biosimilars.

Patients typically rely on their doctors for advice. The trust generated from that relationship provides a potent avenue for reaching patients. Based on understanding of how biosimilars can help control spiraling healthcare costs with no loss of efficacy or safety, clinicians can reassure their patients about switching from a reference biologic to a biosimilar. Patient advocacy groups also can play a role in helping patients to understand and accept biosimilars.

Institutional barriers to biosimilar adoption extend beyond the need for education. The fragmented and multilayered nature of US healthcare necessitates buy-in from numerous parties. For example, in most cases both private and public payers maintain formularies, which are lists of specific drugs for which payers will reimburse clinicians and pharmacists through pharmacy benefit managers. Without inclusion on such formularies, most drugs struggle to gain market share. Biosimilars must gain formulary inclusion to be sold, but formulary coverage differs considerably among payers.

Biosimilars can mitigate the burden of healthcare costs without decreasing therapeutic value for patients. Smart policy decisions can help drive formulary inclusion for biosimilars and simplify their market uptake. A national commitment to educating and persuading stakeholders about the value of biosimilars would give patients expanded access to biologics at reduced healthcare costs. The resources freed from investing in biosimilars could be redirected to support further innovations in drug development.

References
1 Biosimilars in the United States 2020-2024. IQVIA Institute: Durham, NC, 29 September 2020; https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/iqvia-institute-biosimilars-in-the-united-states.pdf.

2 H.R.3590 Patient Protection and Affordable Care Act (Enrolled Bill [Final as Passed Both House and Senate] — ENR) Sec. 7002 Approval Pathway for Biosimilar Biological Products. US Food and Drug Administration: Silver Spring, MD, 2009; https://www.fda.gov/media/78946/download.

3 Biosimilar and Interchangeable Biologics: More Treatment Choices. US Food and Drug Administration: Silver Spring, MD, 12 October 2021; https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices.

Jin Ah Jung, MD, is the leader of medical affairs at Samsung Bioepis, Incheon, South Korea; 82-32-728-0114; bioepisinfo@samsung.com.