With the FDA approval and launch of the first interchangeable biosimilar in the United States in 2021, retail pharmacists are poised to play an increasing role in the future uptake of biosimilars.
Since the first biosimilar was approved in the United States in 2015, physicians have been playing a key role in determining which patients will be treated with a biosimilar versus a reference product. However, with the FDA approval and launch of the first interchangeable biosimilar in the United States in 2021, retail pharmacists are poised to play an increasing role in the future uptake of biosimilars.
To appreciate why pharmacists will be in an even stronger position to support the future of biosimilars, it is helpful to first have some background on interchangeable biosimilars. Interchangeability is a regulatory designation, unique to the United States. It is achieved primarily through the submission of additional data to the FDA, which may be in the form of switching studies, in which patients are switched between the reference product and the biosimilar multiple times to prove no meaningful differences in outcomes.
Practically speaking, interchangeability allows pharmacists to automatically substitute an interchangeable biosimilar in place of a reference product without consulting the prescribing physician, in accordance with state laws.
Today, there is only one interchangeable biosimilar on the market: Semglee (insulin glargine- yfgn), a biosimilar to the long-acting insulin, Lantus (insulin glargine). But Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab), also received approval as an interchangeable biosimilar in fall 2021 and is expected to come to market in 2023.
Additionally, multiple other adalimumab biosimilar candidates are seeking to achieve interchangeability designation, with more approvals anticipated over the next year. As a result, by next year, pharmacists in the retail and/or specialty pharmacy setting could be regularly making decisions about substituting interchangeable biosimilars for reference products, pending a conducive managed care landscape.
To better understand how prepared pharmacists are to embrace the opportunity presented by biosimilars, Cardinal Health surveyed 115 retail pharmacists about their views on biosimilars. The results, published in Cardinal Health’s 2022 Biosimilars Report, indicate that although pharmacists are optimistic that biosimilars will lower costs for patients, questions and concerns remain.
Below are some key takeaways from the survey:
Most retail pharmacists are familiar with biosimilars and the concept of interchangeability, but many have concerns about the use of extrapolation in the FDA approval process.
Pharmacists in our survey report being generally acquainted with biosimilars with two-thirds of respondents (68%) stating they are “somewhat familiar,” while one-quarter (24%) said they were “very familiar.”
Awareness and understanding of the FDA’s interchangeability designation was slightly lower, with only 19% of respondents saying they are “very familiar” and 68% saying they were “somewhat familiar” with interchangeable designation. Despite better than average familiarity, nearly 40% of respondents reported having concerns about the FDA approval process for biosimilars, particularly in relation to extrapolation for other indications where there is no clinical trial evidence.
This indicates a critical opportunity to enhance awareness and understanding of the scientific rigor associated with the FDA approval process for biosimilars to further establish clinical confidence.
Although these results may not be surprising given that interchangeable biosimilars have only been commercially available for a few months, and retail pharmacists were not necessarily positioned to manage biosimilars until insulins (and other select molecules) were transitioned to be managed as biologics from a regulatory standpoint in March 2020, they do suggest that further education for pharmacists is needed.
A majority of pharmacists feel comfortable substituting biosimilars for reference biologics, despite concerns about efficacy among about a third of survey respondents.
While familiarity with biosimilars among pharmacists is still growing, nearly all respondents stated they would be comfortable substituting biosimilars for reference products when they deliver lower costs for patients, with 51% citing they would be “very comfortable“ and 40% saying they would be “somewhat comfortable.”
However, despite the comfort with substitution, when asked about their top concerns related to biosimilars, 31% said they had concerns about efficacy. These responses again suggest the critical need for education efforts around the FDA approval process, which requires biosimilar candidates to demonstrate equivalent efficacy and safety to reference products.
These results can likely also be attributed in part to familiarity biases, which can lead to certain preferences for status quo and are often influenced by past experiences. With biosimilars being a relative new product type for retail pharmacists specifically, there is greater plausibility for this dynamic to occur.
The ability to deliver savings to patients is very important to pharmacists who overwhelmingly expect biosimilars to lead to lower costs.
Although retail pharmacists are still deepening their understanding of biosimilars, the majority are optimistic about the ability of biosimilars to reduce the cost of care for patients. Three-quarters of respondents (74%) said they believe insulin biosimilars are likely to lower the cost of care for patients with diabetes.
In addition, when considering substituting a biosimilar, 93% of pharmacists said cost savings for the patient would be extremely or very important. Slightly fewer (78%) said cost savings for the pharmacy also was “extremely” or “very” important when considering a biosimilar.
Pharmacists in our survey also indicated that lower prices would be the most important factor to helping patients feel more comfortable taking a biosimilar. However, although cost savings associated with biosimilars is important to pharmacists, it is not clear yet what level of price discount may be required to motivate them to recommend biosimilars to their patients.
Pharmacists want additional educational resources to prepare them to speak to patients about biosimilars.
Patient education and counseling will be a critical part of biosimilar adoption, but less than half (45%) of responding pharmacists said they feel very prepared to have conversations with patients about insulin biosimilars. For those companies developing biosimilars that will be dispensed at the pharmacy, this may represent an opportunity to support broader education.
Seven out of ten of pharmacists said “biosimilar 101 materials” would help support their conversations with patients about biosimilars, while 67% said they would rely on biosimilars product fact sheets.
Moving toward 2023
Retail pharmacists are positioned to serve as key change agents in driving biosimilar adoption in the United States as we approach 2023. Because they sit at the forefront of health care delivery as some of the most accessible health care providers, pharmacists will not only serve a primary role in educating patients about biosimilars, they will also be tasked with helping patients navigate the economic considerations, from insurance policies to co-pay assistance, to determine which treatment options will be most cost effective.
This in itself is no small feat, especially as more biosimilars enter the market and managed care decisions continue to evolve—sometimes as frequently as multiple times a year.
Based on our research findings, retail pharmacists are eager to embrace their role with biosimilars, particularly with the expectation of delivering greater access to high quality care at a lower cost. As trained medication experts, pharmacists are well positioned to serve as biosimilar advocates and support the adoption of these critical treatments.
However further support is needed to close knowledge gaps and overcome concerns about efficacy and concepts such as extrapolation. Investing in this stakeholder group and taking action to address potential hesitations represents significant opportunity for biosimilar developers and other key stakeholders.
Equipping retail pharmacists with the tools and resources needed to effectively support the patient journey with biosimilars will help further ensure optimal patient experiences and outcomes, while supporting access to high quality treatment options at a lower cost in 2023 and beyond.