Proper naming of biosimilars is key for patient access and safety, say delegates at WHO INN meeting
Biosimilar drugs should be given the same nonproprietary names as original biologics to ensure patient access and safe prescribing, according to Sumant Ramachandra, Senior VP and Chief Scientific Officer of Hospira.
Speaking on behalf of the Generics Pharmaceuticals Association (GphA) at the WHO's 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland, Ramachandra says Europe has approved biosimilars with the same nonproprietary names as their reference biologics for more than six years in a system that has proved effective.
Biosimilars have also been successfully tracked in the marketplace using their brand name, meaning a separate nonproprietary name is not necessary for keeping track of biosimilars once they are on the market.
Also, the US Affordable Care Act (ACA), under which Congress gave the US Food and Drug Administration (FDA) a pathway to approve biosimilars, did not include any language requiring separate nonproprietary names for biosimilars.
'Different nonproprietary names for a biologic and the biosimilar product modelled from it could create confusion among the clinicians who rely on international and local standards to fill prescriptions for patients, potentially resulting in safety and medication access issues,' he says.
Joerg Windisch, Chief Science Officer at Sandoz Biopharmaceuticals and Chairman of the European Biosimilars Group, agrees that biosimilar products should be assigned with the same INN as their reference products and that introducing a new naming convention would create confusion, compromise patient safety and limit patient access to biologics.
The EGA says the unique product brand name is the best identifier for patients and physicians alike. It is simple, easy to remember and evaluated by the European Medicines Agency to ensure it cannot be confused with the name of another product.