Misperceptions of biosimilars contribute to low acceptance of these products. Two Cardinal Health researchers discuss barriers to understanding and the importance of biosimilar education.
Biosimilar uptake would be more successful and swifter if efforts were made to educate patients and providers about them, wrote Sonia T. Oskouei, vice president of Biosimilars for Cardinal Health, and Andrew R. Kusmierczyk, supervisor of Chemistry, Manufacturing, and Controls at Cardinal, in a new paper.
“In order to overcome any potential hesitation with biosimilars from a scientific or clinical standpoint, education will need to be at the forefront,” they said.
According to the review, the top reasons physicians and patients resist using biosimilars include:
The report said education can be a powerful factor in getting physicians to employ 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 reported little or no confidence in these agents. Yet, following an extensive EU effort to increase biosimilar knowledge, a 2015 survey revealed “drastic changes” in gastroenterologist attitudes: “47% of respondents felt either totally or very confident with biosimilars in 2015 compared with only 13% in 2013,” the report stated.
“Moreover, the 2015 survey revealed more than a 50% reduction in safety concerns with immunogenicity associated with biosimilars,” Oskouei and Kusmierczyk wrote.
Market adoption of infliximab biosimilars in the European Union also picked up, giving these agents a 50% share of the infliximab market (vs the originator biologic) by 2017, they said.
US Biosimilar Attitudes Improve
In the United States, the signs are that understanding and acceptance of biosimilars among rheumatologists has improved significantly.
A 2016 survey of US physicians (N = 102) who were mainly rheumatologists indicated that just 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.”
A study of rheumatologists in 2019 (N = 320) found that 83% were “very familiar” with the FDA’s biosimilars definition. However, just 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,” Oskouei and Kusmierczyk said.
On the patient side, efforts need to be made to overcome the “nocebo effect,” they said. Patients often have never heard about biosimilars and, of those, not all would be confident about using one even if recommended by their physician.
When patients 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.
Negative outcomes from use of biosimilars can feed negative perceptions about them and add to physician and patient hesitancy to use these agents—another reason why efforts have to be made to overcome nocebo through education.
“The importance of patient education to mitigating the effect has been recognized and researchers are beginning to be able to measure its impact,” Oskouei and Kusmierczyk said.
Overall, in the struggle to boost acceptance via education, data can play a major role. “Data are always the best argument and continued evidence development is rightfully at the top of the list of action items,” they wrote.
Other report recommendations include: