In the continuing debate over the uptake of biosimilars, FDA recently put a stake in the ground by recommending in a new labeling guidance that all biosimilar products contain only a biosimilarity statement, even for products designated as interchangeable. Discussing the proposed change, Sarah Yim, M.D., FDA's Director of the Office of New Drugs' Office of Therapeutic Biologics and Biosimilars, explained that one purpose of the change is that it's FDA's position that all biosimilars – including those designated interchangeable – “meet the same high standard of biosimilarity for FDA approval, and both are as safe and effective as the reference product.”
The proposed change in the labeling requirement will not have any impact on automatic substitution at the pharmacy level, but it is in part designed to tackle complaints that the uptake of biosimilars is being depressed over concerns that products designated only as biosimilar are less safe or effective because they don't have an interchangeable designation. According to Dr. Yim, the purpose of labeling is to provide safety and efficacy information to doctors, but the interchangeability designation is only relevant for the pharmacy and should not drive prescribing decisions.
Will the removal of the interchangeability statement from labels have an impact on biosimilar uptake, causing a corresponding reduction in drug costs? That's certainly unclear, but FDA is apparently willing to use its regulatory guidance powers to promote biosimilar competition.
“Prescribers can prescribe both biosimilar and interchangeable biosimilar products in place of the reference product with equal confidence that they are as safe and effective as their reference products.
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