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Health professionals have expressed concerns regarding consistent naming standards, the regulatory process surrounding the approval of biosimilar drugs, and the lack of education they have about biosimilars.
Attitudinal, practical, psychological and economic factors have hindered more widespread uptake and adoption of biosimilar drugs and must be addressed if biosimilars are to achieve their potential in decreasing costs of treatment and increasing patient access, according to a review published in the Journal of the American Medical Association Oncology.1
A wealth of prior literature has focused on the economic barriers to the uptake of biosimilar drugs; this current review is the first to the knowledge and highlight non-economic barriers and their role in limiting uptake of biosimilar drugs in the United States.1
Targeting these barriers–both economic and non-economic–is essential, as the commercialization of biosimilars has been lacking since the first biosimilar drug was approved in 2015. This is especially apparent in the field of oncology, which becomes increasingly costly each year; in 2022 alone, $88 billion was spent on cancer drugs.1
The authors of this review tackle a series of psychological, educational, and attitudinal factors among patients seeking biosimilar drugs and health care professionals that have limited biosimilar uptake.
Beginning with the naming conventions for biosimilars, the review authors critiqued the process by which biosimilar drugs are coined and presented to the public. In particular, the use of the “interchangeable” designation was singled out as having “the potential to sow further confusion, especially with respect to confidence regarding safety and efficacy.”1
This distinction, which designates a biosimilar as being sufficiently like the reference product that they can be swapped out without physician consultation, can suggest that a biosimilar that is not deemed “interchangeable” is not safe or effective, according to the review authors.
Education gaps regarding biosimilars among clinicians is another pertinent issue hindering biosimilar uptake. The authors cited Sarnola et al.’s systematic review of physicians and their perception of biosimilars, which found that 2% to 25% do not know what biosimilars were and could not provide an accurate definition, and 65% to 67% had concerns regarding biosimilars and prescribing them.2
In attempting to close the knowledge gap and promote health care knowledge regarding biosimilars, the review authors determined that health care professionals need further education in these areas: general information, biosimilar safety, general efficacy and comparative efficacy to the reference product, interchangeability and extrapolation.1
Prescriber concerns surrounding the safety and efficacy of biosimilars also remain a sticking point in increasing uptake of biosimilars across the country. Tying in with the lack of education surrounding the industry, pharmacists have longstanding apprehension regarding immunogenicity, indications, interchangeability, and safety practices.1
Many of these safety concerns are driven by the slight differences in the manufacturing process for a biosimilar compared to their reference product. Further, research backing a biosimilar towards FDA approval aims to show they are highly similar to the reference drug rather than establishing the safety and efficacy of the biosimilar, according to the study authors.
Individual differences in personality are also accounted for as a potential attitudinal factor. There is a lack of data surrounding the influence that personality has on biosimilar uptake, but “some personality traits, in particular, have been show to reliably predict long-term health outcomes and longevity,” the investigators wrote.
Higher levels of conscientiousness, as well as avoiding smoking and undergoing exercise, are personality traits that been found to influence health-related behaviors and, importantly, dictate health-related attitudes. The latter is especially noteworthy and could be relevant when making decisions regarding biosimilar acceptance.1
There are also several setting- and system-specific obstacles to biosimilar acceptance. Overlap among health care professionals in the settings and systems they are embedded in pose challenges to the widespread adoption of biosimilars due to a lack of consistency across settings. Additionally, litigation by reference drug manufacturers has led to the number of biosimilars on the market not keeping pace with the number of products approved by the FDA.1
Despite the obstacles that hinder biosimilar use, there are common factors that appear to influence readiness to adopt biosimilar drugs and motivate those who are hesitant. These include approving biosimilars as safe and effective and the cost savings associated with the use of biosimilars.1
Above all, it is up to clinicians and pharmacies to become educated on biosimilars so they can provide accurate information to patients. As the review authors note, “education can be a key strategy to increase awareness, knowledge and uptake of biosimilars.”
Additionally, Christina Bookwalter, PharmD, MS Med, BCPS, BCACP put it starkly when discussing the role of pharmacists in increasing biosimilar uptake: “At the end of the day… the pharmacist must ensure the patient receives proper medication education on the product.”3
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