NORD says distinguishable names for biosimilars critical

The National Organization for Rare Disorders has weighed in on the conflict over biosimilars naming, asserting that distinguishable non-proprietary names are needed to support surveillance and tracking of adverse events, as well as potential differences in efficacy. Common names could make it impossible to collect accurate post-approval data, and post-market data is particularly important for patients with rare diseases, NORD Public Policy VP Diane Dorman told BioCentury.

"Within the larger population, persons with rare diseases have particular concerns because of the frequency of idiosyncratic reactions they have to medicines. This can be adverse events, but it could also be a sub- or supra-potent response to the medicine (efficacy)," Dorman said. "Many rare disease patients are treated with medicines with a primary indication that is not for their specific disease, and tracking of results helps clinicians determine drug efficacy in various patient populations." ...