BioCentury reports that the Generic Pharmaceutical Association has requested (via Citizen's Petition) that the FDA allow biosimilar and interchangeable biologics to use the same international non-proprietary name (INN) as reference biologics. GPhA said requiring different INNs for biosimilars and the original biologic would "inaccurately suggest that these products have meaningful clinical differences for patients."
The petition asserts that FDA lacks legal authority to require separate INNs for biosimilars. GPhA also noted that FDA has allowed originator biologics, including antihemophilic factors, to share an INN even if they differ in manufacturing method.
The agency is developing a guidance document on naming biosimilars and interchangeable biologics. According to Rachel Sherman, CDER’s Director of the Office of Medical, the naming policy will be designed to ensure that products can be tracked and traced, "Pharmacovigilance is our prime concern; we need to know who is getting what." noted Sherman.
Smart money (and savvy public health practice) predicts the petition will be denied.
