Despite more than a decade of biosimilar availability, the need to educate providers and patients alike, avoid misinformation, and update what is taught remains a significant need. At the GRx+Biosims meeting, we heard from FDA, pharmaceutical companies, and other stakeholders on the issue of biosimilar education.
Several years ago, the FDA launched a project to create a model biosimilar curriculum or toolkit that can be used in pharmacy, medical, and nursing schools to educate students about the equivalence of biosimilars to reference drugs, the biosimilar approval pathway, and what biosimilars represent to the healthcare system. BR&R reported on the FDA’s 2021 launch of the program.
Not only was this effort a major tool to combat misinformation about biosimilars, but it sought to ready the next generation of healthcare professionals to take advantage of biosimilar competition and savings. Several aspects of biosimilars and the pathway have changed in the 5 years since the program’s launch. For example, the mandate for comparative efficacy studies is no longer enforced. The need to use a US-licensed reference product for analytical comparisons has been changed. The availability of biosimilars in several new drug categories (and specialties) has broaden considerably. The FDA now believes that interchangeability should no longer be a separate designation. And confidence in the utility of biosimilars has grown with their use.
At last week’s GRx+Biosims meeting in North Bethesda, Sara Yim, MD, Director, Office of Therapeutic Biologics and Biosimilars (OTBB), at FDA, indicated that biosimilar education needs to evolve with the times: “At first, we let people get some comfort with biosimilars by having the clinical data there. We’re going to have to update our materials to allow them to connect the dots with analytical data. Even regulators are uncomfortable going without the clinical studies. Updating our education is very important.”
This was confirmed by Sarah Ikenberry, MA, OTBB’s Associate Director for Stakeholder Engagement and Education, who said that this updating process is underway. “The biosimilar education site is successful,” but disseminating it and gaining greater utilization is very difficult in the academic setting. “It’s tough to compete with everyone’s inboxes,” she commented.
Whose Responsibility Is Biosimilar Education?
The problem for pharmacy schools has always been that the curriculum is packed already. Jennifer Adams, PharmD, EdD, Associate Dean for Academic Programs, Idaho State University College of Pharmacy confirmed, “We can’t possibly cover every topic within the formal Pharmacy College curriculum. We have used some of FDA’s biosimilar education resources.”
Instead, Dr. Adams wondered whether continuing education (CE) is a more viable route to deliver the education. “Pharmacists are required to have 15 CE hours per year. They look for convenient ways to accumulate those educational hours, and it is not specifically looking for subjects where the need exists.”
One logical direction to turn for education is the biosimilar manufacturers themselves. However, they aren’t generally staffed for the effort. Jeffrey Robinson, PhD, Head of US Medical Affairs, Sandoz, noted, “We have four [medical science liaisons], which is not large enough to cover all our prescribers and pharmacists. We had a fairly large CME [continuing medical education] budget in the past, but this has dwindled over time.”
Gregg Sherman, MD, Chief Medical Officer, Haymarket Medical Education Group, added that even after participating in a CME program on biosimilars, “73% of physicians were not confident they could describe the similarity and differences between biosims and their reference products.”
The challenge may be even more difficult today, because of the change in clinical study requirements and greater reliance on drug characterization data, said Dr. Robinson. “When showing physicians information on analytical assays, their eyes tend to glaze over.” And one thing has not changed for physicians, he noted: “Rather than talking about biosimilars, doctors are much more interested in the next new innovator product!”
Ms. Ikenberry believes that biosimilar education is “a shared responsibility. Where are the greatest opportunities for collaboration?” Everyone is in general agreement that the FDA’s education materials are quite good. Sandoz often refers people to the FDA website, said Dr. Robinson.
Approaches That Could Improve Biosimilar Education
It was suggested that physicians need some assistance in talking to patients about their need to switch to a biosimilar. This is often prompted by a change in drug coverage, according to Dr. Robinson. “It could be a difficult conversation with their patient if the health plan won’t cover their reference product any longer.” The question seems to be how to distill that information down so that the patients, as well as healthcare practitioners, will understand it, added Dr. Adams.
In CE programs, a standard component is a needs assessment. Dr. Sherman commented that he has not seen any dedicated healthcare practitioner surveys that assess their biosimilar education knowledge gaps. Pharmaceutical companies do market research often, but these knowledge gaps are not consistently queried, confirmed Dr. Robinson.
Another route is the use of direct-to-consumer and/or physician-education advertising. The former is still not utilized, and despite some marketing of specific biosimilars to prescribers, general biosimilar awareness campaigns are not visible. It is likely that a biosimilar trade group would have to take the initiative of sponsoring such DTC advertising. Funds for biosimilar marketing are more available during launch campaigns by individual manufacturers, but these budgets may be limited by anticipated revenues.
For these reasons, it is likely that the FDA will be relied upon heavily as the principal source for up-to-date, readable, and comprehensive biosimilar education for the years to come.
This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.
