Last week’s AAM Access 2021 virtual meeting generally danced to a positive beat on the progress of biosimilars today and in the near future. In her keynote address, Acting Food and Drug Administration Commission Janet Woodcock, MD, emphasized that the agency’s biosimilar development and consulting program has experienced increasing engagement. Dr. Woodcock stated, “As of May 1, 94 programs are enrolled in the biosimilar development program. CDER has received meeting requests to discuss the development of biosimilars for 43 different reference products.” This likely includes interest over many of the biologic products categorized as transitional until March 2020 (e.g., growth hormones, follitropins, and of course, the insulins). Forty-three reference products is a big number, however; this must include development programs for several new reference biologic targets.
Dr. Woodcock’s vision for a bright biosimilar future will require additional support on the part of the key stakeholders, including prescribers, payers, and other policy makers. Those observing the industry for some time realize that providers who have the most experience with biosimilars have offered the least resistance to the use of newly available biosimilars. Oncology has been a primary example. Since the initial availability of Zarxio® in 2015, this agent has become the dominant filgrastim product. Providers have presumably gained a high level of confidence in its safety and efficacy record (as well as the reliability of Sandoz’s supply chain), supporting its ongoing use. With this initial experience in the G-CSF category, oncologists quickly prescribed bevacizumab, trastuzumab, and rituximab as these agents were launched over the past 18 months. In the US, of course, infliximab biosimilar prescribing remains depressed, and gastroenterologists, in particular, may have less experience in prescribing (and therefore confidence in) the biosimilar versions of Remicade®.
For categories that may be new to biosimilars in upcoming years, better education of providers and healthcare professionals on biosimilars will play an important role. That starts today with the training students receive in medical, pharmacy, and nursing schools. The FDA recognized this, undertaking a project in 2019 to survey how biosimilar education is provided to students. Dr. Woodcock realized that this is no small question, as it underlies the importance of healthcare personnel’s comfort levels surrounding biosimilars.
Pharmacy Training in Biosimilars
In our own conversations with FDA, the American Association of Colleges of Pharmacy, the Academy of Managed Care Pharmacy, and with other leaders, it has been apparent that student education about biosimilars is very inconsistent. For example, in the college of pharmacy setting, we’ve received anecdotal reports of its discussion within the therapeutics curricula, the drug regulatory track, during pharmaceutical management training, or nothing much at all. In a couple of instances, biosimilars are addressed as part of satellite programs offered to students, which may be voluntary. These can provide a fuller introduction to the field, offering time for questions and answers, but is an hour or so adequate time to address such an important tool in controlling specialty pharmaceutical costs? In any case, it does have the effect of reaching a critical healthcare audience who will be responsible for educating patients and helping to make coverage policy decisions. At the very least, it does ensure that the terminology is not foreign to pharmacy school graduates.
One very difficult challenge is time. Within graduate programs, curricula are packed with traditional education on pharmacology and pharmacodynamics, education on disease and epidemiology, practice management, and the healthcare system in general. Finding space or an opportunity for new or developing educational topics can turn into a debate over priorities.
We have not had similar experiences on the medical school side of the fence. We know that experience breeds confidence in biosimilars. How will medical professionals consider the upcoming launch of the ranibizumab biosimilars for ophthalmologic indications? That’s new territory. Prescribers’ understanding of biosimilars’ role and the foundation for their FDA approval become even more critical to the successful launch and swift uptake of these agents.
Although Commissioner Woodcock mentioned the biosimilar education initiative in her keynote address, it is unclear if the project has gone beyond a basic survey of medical, pharmacy, and nursing school deans. Steps to provide a model core curriculum in biosimilars, or at least a consistent method for exploring the topic in graduate healthcare training, should now be a priority.