Biosimilars are poised to bring significant cost-savings opportunities in oncology, while maintaining high-quality patient care. Although some providers are actively using biosimilars in their practices, others feel challenged with navigating the economic, clinical, and operational implications of adopting these agents.
Biosimilar uptake would be more successful and swifter if efforts were made to educate patients and providers about them, wrote Sonia T. Oskouei, PharmD, Vice President, Biosimilars, Cardinal Health, Atlanta, GA, and Andrew R. Kusmierczyk, PhD, Supervisor, Chemistry, Manufacturing, and Controls, Cardinal Health, in a recent article published in Pharmaceutical Medicine. The authors identified key knowledge gaps of healthcare professionals and patients and proposed a number of strategies that can help remove the barriers to successful biosimilar adoption.
“In order to overcome any potential hesitation with biosimilars from a scientific or clinical standpoint, education will need to be at the forefront,” they wrote.
According to Drs Oskouei and Kusmierczyk, the primary reasons that physicians and patients resist the use of biosimilars include the following:
- Immunogenicity. This is the tendency of a biologic to provoke an immune reaction that could change the clinical profile of the drug, although “the risk of immunogenicity with switching to a biosimilar has not been shown to be any greater than switching between 2 batches of any [originator] biologic,” they noted, adding that more evidence would be helpful in addressing concerns regarding immunogenicity.
- Regulatory requirements. In its approval pathway, the FDA stresses physicochemical characterization of the biosimilar molecule, or “analytical studies,” and underweights clinical efficacy trials, which are less helpful in validating biologic equivalence. Providers need to be educated on the scientific rigor behind the analytical rationale.
- Extrapolation. Biosimilar manufacturers typically obtain approval for just 1 indication of an originator biologic, and after that the FDA is OK with physicians using biosimilars for all approved indications of an originator. “Studies have revealed greater provider hesitation with biosimilar utilization in indications that were granted via extrapolation,” wrote Drs Oskouei and Kusmierczyk. Providing physicians with more training on critical quality attributes that justify biosimilar approval would alleviate these concerns.
- Interchangeability. Biosimilar manufacturers can obtain interchangeability designations for their products, allowing pharmacists to make substitutions without physician intervention. “Interchangeability is a regulatory designation, not a clinical one,” the authors stated, adding that education can reinforce the concept that there are no clinical differences between biosimilars and interchangeables.
Are Efforts to Better Educate Providers and Patients Making a Difference?
The article explained that education can be a powerful tool for getting physicians to adopt biosimilars, noting the difference over time in survey responses from gastroenterologists in Europe who were asked to describe their confidence in biosimilars.
In a 2013 study, the majority of respondents reported that they had little or no confidence in biosimilars. However, following a concerted effort to increase knowledge of these agents, a 2015 survey revealed significant changes in attitudes, with 47% of respondents feeling either totally or very confident with biosimilars in 2015 compared with only 13% in 2013.
“Moreover, the 2015 survey revealed more than a 50% reduction in safety concerns with immunogenicity associated with biosimilars,” Drs Oskouei and Kusmierczyk wrote.
In the United States, the understanding and acceptance of biosimilars among some providers appears to be improving significantly.
A 2016 survey of US physicians (N = 102), who were mostly rheumatologists, showed that only 38% described themselves as “extremely familiar with the FDA’s definition of biosimilars,” which is that a biosimilar is “highly similar to and has no clinically meaningful difference from an existing FDA-approved reference product.”
In contrast, a study of rheumatologists in 2019 (N = 320) indicated that 83% were “very familiar” with the FDA’s biosimilars definition. However, only 34% said they were likely or very likely to switch patients not doing well on the reference product to a biosimilar, which suggests that “a not-insignificant number of US rheumatologists still have knowledge gaps on the concept of biosimilarity,” Drs Oskouei and Kusmierczyk wrote.
For patients, efforts need to be made to overcome the “nocebo effect,” they stated. Patients often are not aware of biosimilars or are hesitant about being prescribed these agents even when they are recommended by their physicians. When patients who are lacking confidence are treated with biosimilars, there is a documented potential for treatment to fail, and this is described as the nocebo effect.
“The magnitude of this effect is not fully understood and could vary with disease state, but several recent studies on infliximab and etanercept biosimilars suggest an effect on the magnitude of 1 in 8 patients,” they wrote.
The authors also emphasized the important role that data can play in boosting confidence in the safety and efficacy of biosimilars. “Data are always the best argument and continued evidence development is rightfully at the top of the list of action items,” they explained.
Moving Ahead
Drs Oskouei and Kusmierczyk listed the following action items that can be implemented to further improve understanding and acceptance of biosimilars:
- Standardized treatment guidelines. These would help to convince providers about the value of biosimilars and would also work by playing on the leverage that comes from peer confidence. By following good standards, physicians would achieve better outcomes and thereby improve their confidence in these products.
- Initiate education early. Evidence has shown that younger healthcare providers are less familiar with biosimilars and less likely to prescribe them, so biosimilar education programs during medical training could improve usage. In addition, teaching the general public about biosimilars could prepare them to be more accepting of biosimilars if they become patients.
- Patient messaging. Messaging tools with appropriate language can be effective in addressing patients’ concerns.
- Power of nurses. Nurses have been shown to be very influential when it comes to educating and reassuring patients about biosimilars.
“Improvements in education must be part of a broader uptake strategy, including effective healthcare delivery models and stakeholder incentives, if the promise of increased access and affordability offered by biosimilars is to be realized,” Drs Oskouei and Kusmierczyk concluded.
Source: Oskouei ST, Kusmierczyk AR. Biosimilar uptake: the importance of healthcare provider education. Pharmaceut. Med. 2021;35:215-224.