Amgen Statement on GPhA Citizen Petition on Naming for Biologics
We are pleased that the Generic Pharmaceutical Association (GPhA) agrees with Amgen's longstanding view that the U.S. Food and Drug Administration should apply a consistent naming policy to all biologic medicines. We are disappointed; however, that the GPhA has resorted to framing the debate between identical and unique names. We believe that this presents a false choice.
As a biologics and biosimilars manufacturer, we feel strongly that all biologic medicines need a distinguishable component in their non proprietary (proper) name. This means that patients, caregivers, healthcare professionals, regulators and industry can more readily and accurately identify, investigate and report adverse events.
To that end we are seeking distinguishable non proprietary names (common root and a distinguishable component) for our biosimilar products. Put patients first and sound policy will follow.