Dr Pamela Becker: Bar Is Set Very High to Meet Biosimilar Definition

The bar is set very high in terms of the biosimilar requirement definition, and physicians who are hesitant about substituting biosimilars for treatment should not be worried about the perceived differences—especially because of the rigorous examination they received before FDA approval, according to Pamela S. Becker, MD, PhD, professor of medicine in the Division of Hematology at the University of Washington School of Medicine.

Transcript (slightly modified)

Why do you think some physicians are hesitant about substituting their patients’ treatment with a biosimilar and how can we overcome that barrier?

I believe it may be related to the same hesitation to using a generic drug, that I think they perceive that there could be differences. But in actuality, having just reviewed all of the details of the steps in the process that the first biosimilar went through—in terms of physical-chemical comparison, in terms of pharmacokinetics and pharmacodynamics, clinical trial comparison—and seeing just exactly how exacting that proof was, I believe that there shouldn’t be hesitation. The bar is set very high in terms of how similar is required in order to meet that biosimilar requirement definition.

Is there a need for patient education on biosimilars?

I think there’ll be the same hesitation on having a biosimilar in terms of the concern that it’s less effective in some way or that there’ll be other side effects. But the side effect profiles and the efficacy have to be proven before the FDA will consider that approval. So in some ways I feel like the regulation is so strict that I don’t anticipate that there’ll be new problems.