Biosimilars: All You Need is Trust

Contributors : Amy Duval, M.Res. Senior Director, Biosimilars

Publish date: 03 Nov, 2017

Key stakeholders in the uptake of biosimilars, including manufacturers, regulators, physicians, and patients, all have an important role to play in the success of these drugs. A key theme arising from several discussions during the World Biosimilars Congress in Basel this week was one of trust; specifically that stakeholders need to learn to trust the decisions made by others in order for the puzzle surrounding biosimilar use to be solved.

There are often calls from physicians for more clinical data on biosimilars to be made available in order to support their uptake and use. During the conference, it became clear that the manufacturers and regulators present believed that evidence used to secure biosimilar approval should also be sufficient to allay any physicians concerns and facilitate prescribing, i.e., physicians should trust their regulators. To facilitate physician trust, education is something that regulators are tackling. For example, the EMA has produced an information guide on biosimilars, the U.K. NHS has developed a resource for oncology biosimilars education through its Cancer Vanguard, and the FDA has rolled out education materials on biosimilars. Assuming physicians are aware of biosimilars and how they are assessed, the sentiment from many attendees at the conference was that no further data beyond what is required by regulators for approval should be needed to secure biosimilar uptake.

In order for the next piece of the puzzle to come together, patients also need to trust physicians who prescribe biosimilars. Different viewpoints were expressed on this topic at the conference; while many championed patient education materials to aid understanding and acceptance of biosimilars, others took a more direct approach, stating that patients should trust their doctors, and this should be enough for patients to accept the care they are recommended.

Even once a patient has been prescribed a biosimilar other key stakeholders can influence the use of these drugs. For example, nursing staff are burdened with many of the logistical issues that come with switching to a biosimilar. In order to encourage these stakeholders to use biosimilars, they too need to better understand these drugs. This brings us back to the point about education, and that all healthcare workers, not just physicians, need training in order to facilitate healthy uptake of biosimilars.

So, if physicians trust regulators and patients trust physicians this could be an important paradigm in facilitating biosimilar uptake, and this trust could be fuelled by education efforts. However, education may not be the straightforward answer that manufacturers and regulators hope. Decision Resources Group research indicates that when Truxima launched in Germany for RA and NHL subpopulations, the majority of surveyed physicians believed it had been clinically assessed in a greater number of diseases than in reality. When physicians were detailed on the trials that had actually taken place and led to its approval, most thought it should have been only available for indications which were clinically evaluated, rather than approval being extrapolated to additional indications by the EMA. Perhaps physician education may lead to more questions than securing trust in regulatory decisions, and the educational resources required to ensure all stakeholders are fully comfortable with biosimilars may be greater than anticipated.

Ultimately, generating trust and education will lead to a likely cyclical uptake model for biosimilars; education and increased trust in regulators are tools to break into this cycle by encouraging an increase in physician prescribing of biosimilars (and the resulting increased understanding among healthcare workers and reassurance to patients). Eventually, this increased prescribing should result in increased comfort and familiarity with biosimilars for all parties, which in turn will facilitate more prescribing, and so on. The challenge is making sure the education and trust are as effective and rapid as possible in breaking into this cycle.

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