by Renee Klink, Social Media Director
The Alliance for Safe Biologics and EuropaBio recently released results of a survey of 470 European physicians’ views on biosimilar naming. Key findings indicate that almost a quarter of doctors in Europe “can’t define or haven’t heard of biosimilars.” Further, respondents stated that having the same name for the biologic and biosimilar drug indicates the medicines are identical.
In recent comments to the Federal Trade Commission about U.S. biosimilar naming regulations, the Alliance for Patient Access together with 14 other health advocacy organizations called for patient safety to be the utmost concern when examining greater patient and provider access to more affordable FDA-approved biologic medicines. With regard to naming the groups stated, “Given the vast differences between chemical compounds and biologics/biosimilars, we are among those urging the FDA to adopt unique names for biologic products including biosimilars rather than requiring biosimilars and their innovative reference product to share the same name.”
While most traditional drugs have structures that are consistent and known and can be reproduced easily with the same results, biologics are made from living cells and often tailored for an individual patient’s condition, like cancer or multiple sclerosis. Biosimilars will be similar, but not identical, to their reference products, and so it would be confusing for these products to share the same names.
International institutions continue to debate policy issues surrounding biologic products. The World Health Assembly will convene in Geneva in late May. Among the topics on the agenda are resolutions regarding naming of biologic therapies and the terms for substitution.
Regulatory agencies in the U.S. and globally must balance the need to ensure patient safety with the desire for more access to treatments, all while laying the groundwork for physicians to deliver the most appropriate course of treatment for their patients.