U.S. Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA–2019–N–1132 for “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products.”
ASHP is pleased to submit comments regarding biosimilar and interchangeable insulin products. ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s nearly 50,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.
ASHP has long supported the development and implementation of policies that promote increased patient access to less expensive biologic products. Given the insulin price spikes in recent years, we are hopeful that insulin biosimilars will significantly reduce cost pressures for patients. In order to meet that potential, we encourage the FDA to take action in four areas: interchangeability, education, naming and competition.
- Interchangeability: ASHP applauds FDA for finalizing its interchangeability guidance. We hope that a final guidance will encourage new applications, thereby increasing competition around insulin products. Although somewhat removed from FDA’s purview, we note that biosimilar uptake is also impacted by state laws that govern substitution of biosimilar products. On the basis of patient safety, many state laws restrict pharmacist substitution of biosimilar products to a higher degree than for small-molecule drugs. As interchangeable insulin products enter the marketplace, these laws have the potential to adversely impact their uptake. Because some state laws include sunset provisions, there is an opportunity to educate policymakers regarding biosimilar safety and quality and to reduce impediments to substitution that are not supported by clinical and/or postmarketing surveillance data.
- Education: ASHP believes that FDA is best situated to provide unbiased and objective information about all biosimilar and interchangeable products, including insulin. We urge FDA to undertake a full-scale biosimilars education and awareness campaign, targeting clinicians, state policymakers, and the general public, to build a foundation of trust for these products. Given lingering public skepticism about generic products more than a decade after the introduction of the Generic Drug User Fee Act, it is essential to quash misinformation about biosimilars as early as possible. To reach the broadest audience, we encourage FDA to produce educational materials in accessible formats, including webinars and podcasts. ASHP recognizes that mounting this type of campaign is resource-intensive, and we are prepared to advocate for increased resources to support FDA in this effort.
- Naming: As FDA is aware, ASHP advocated adoption of a biosimilar naming framework that mirrored the framework for small-molecule drugs and their generic counterparts, relying on a shared nonproprietary name without suffixes. ASHP remains concerned that FDA’s framework for biosimiliars nonproprietary naming may confuse clinicians and complicate postmarket surveillance. Specifically, because four-consonant, non-meaningful, unpronounceable suffixes are unlikely to be readily recalled or associated accurately with specific products, names with these suffixes may be unlikely to achieve FDA’s goals of product recognition and uptake by prescribers, patients, and others. We recognize that FDA does not intend to retroactively extend the biologics naming convention to insulin and other transition biologics. However, we ask that FDA confirm our understanding that the naming paradigm will apply to new insulin biosimilar and interchangeable products.
- Competition: ASHP advocates policies that strengthen competition in the biosimilar marketplace and we thank FDA for its work to speed application approval and reduce barriers to market entry. We encourage the FDA, to the extent of its authority, to address patent manipulations that unduly impede new biosimilar and interchangeable products. ASHP is a member of the Campaign for Sustainable Rx Pricing (CSRxP) which seeks to advance market-based solutions to promote transparency, competition, accountability, and value in prescription medications. We urge FDA to maintain a dialogue with CSRxP, patients, and other healthcare providers to ensure the creation of a robust biosimilars marketplace.
ASHP thanks the Food and Drug Administration (FDA) for the opportunity to comment on this issue. Please contact me if you have any questions on ASHP’s comments. I can be reached by telephone at 301-664-8698 or by email at [email protected].
Jillanne Schulte Wall, J.D.
Director, Federal Regulatory Affairs