With the US Food and Drug Administration’s (FDA) intentionally leaving out language on INNs in its biosimilar approval law, Amgen and Mylan, along with the Generic Pharmaceutical Association (GPhA), came out in favour biologics and their bioequivalents sharing the same INN.
Now drugmaker Hospira - who recently received marketing approval in Europe for its monoclonal antibody biosimilar, Inflectra – has announced it too is in favour of the nomenclature at the WHO's 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland.
“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,” noted Hospira’s Senior VP and Chief Scientific Officer Dr. Sumant Ramachandra.
“Biosimilars have been successfully tracked in the marketplace using their brand name, meaning a separate nonproprietary name isn't necessary for keeping track of biosimilars once they're on the market.”
However, not all industry is in favour of such naming. A joint letter sent to the FDA’s Commissioner, Margaret Hamburg in 2012 from the Biotechnology Industry Organisation (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) called for unique names for all biological products, whether interchangeable or not.
“We believe that FDA adoption of a system that assigns the same name to products that are similar, but not the same, would create confusion for physicians and patients and risk patient safety by hindering effective pharmacovigilance,” the letter said.