Investigators Recommend a More Systematic Effort to Get Biosimilars Adopted

Physicians and patients worldwide have been slow to use biosimilars, despite clinical trials demonstrating that approved biosimilars are as safe and effective as the reference versions. A recent literature review by Canadian investigators has concluded that, in many countries, a far more systematic effort is required to achieve widespread adoption of biosimilars in clinical practice.

“We [observed] a lack of systematic description of implementation design and evaluation and a paucity of in-depth and engaged research to understand stakeholders’ pragmatic considerations and the knowledge, messages, and meanings that shape clinician and patient decisions to choose biosimilars,” the authors write.

The availability of biosimilars in Canada is about to greatly expand, with 13 biologic drugs losing market exclusivity by 2022. In the Canadian province of British Columbia, a forced switching policy was adopted in 2019 that requires patients in the public health system to use biosimilars for rheumatology and diabetes instead of reference products. The Alberta and Ontario provincial governments both have decided to implement forced biosimilar switching policies.

The authors of the current study conclude that, wherever biosimilars are available, adoption rates may be poor without concurrent education and clear understanding of the clinical environments in which these agents would be prescribed.

The reluctance of physicians and patients to choose biosimilars is widely documented. However, according to the authors, missing from the literature is “implementation science,” evidence on how to transition biosimilars to routine care. In the United States, for example, past investigation has demonstrated a significant need for evidence-based education on biosimilars in the areas of understanding bioequivalence and differentiating between biologics and biosimilars, the authors note.

Acceptance of an innovation into regular clinical practice requires stakeholders to change behaviors or adopt new technologies. Investigators used a diffusion-of-innovations model to examine factors and processes influencing the spread and sustained use of innovations in healthcare.

The authors note that adoption of biosimilars has improved in Scotland and the United Kingdom because of educational measures, but in Germany and Belgium, where biosimilars are available but there is no systematic educational effort, physicians generally prescribe reference products for first-line therapy.

The authors recommend encouraging use of biosimilars at the start of treatment, citing studies on the reluctance of patients to switch from an originator biologic once they are enjoying favorable results. In addition, “when the clinical stakes are high due to the debilitating nature of the illness being treated, there is more anxiety about change,” the authors write.

Regulatory agencies have taken steps to promote biosimilar use. The FDA’s Biosimilar Action Plan, for example, facilitated data sharing with regulatory agencies from other countries to accelerate the approval process for biosimilars already approved in Europe. Both the FDA and the European Medicines Agency (EMA) have provided resources for prescribers on the evidence supporting equivalence of biosimilars to address knowledge gaps.

However, few physician organizations and patient advocacy groups, which are influential for prescribers, promote biosimilar use. The authors of the review cite this as a significant problem. Getting physicians to apply new knowledge into clinical practice requires them to receive persuasive information from many sources: practice guidelines from medical authorities, clinical studies, colleagues and opinion leaders, conferences and continuing education, marketing, experience, and patient preferences.

The advantages of biosimilars are clear when looking at their clinical equivalence to reference products and lower cost. “The advantages of biosimilars versus biologics are less clear when considering adopters’ beliefs and values surrounding care. In Germany and Belgium, where biosimilars are accessible, physicians choose a biologic over a biosimilar for first-line therapy and prioritize treatment efficacy over cost-effectiveness,” the authors write.

They note that the potential for experimentation with biosimilars without risk is limited and this could be a challenge for adoption.

The authors caution against mandatory switching to biosimilars, which they warn does not change ingrained attitudes. Norway mandated automatic switching from infliximab to 1 of 2 biosimilars, with little effect on the market share of the biosimilars.

Subsequently, Norway launched a campaign involving stakeholders and providing education on biosimilars and adjustment of pricing, a more successful strategy that resulted in the 2 approved biosimilars reaching a majority market share.

Reference

Khan D, Luig T, Mosher D, Campbell-Scherer D. Lessons from international experience with biosimilar implementation: an application of the diffusion of innovations model. Healthc Policy. 2020;15(3):16-27. doi: 10.12927/hcpol.2020.26133.