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Biosimilar naming system comes under fire

Industry groups, drug companies criticize proposals citing usability issues.

A number of industry groups and drug companies are speaking out about the naming of biosimilars, worrying that the more complicated it becomes the less likely it will be for doctors and pharmacists to prescribe them.

During the World Health Organization's 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Hospira argued that it is essential for biosimilar drugs to be given the same nonproprietary names as original biologics.

Their reasoning? To ensure that patients receive the full benefit of greater access and lower costs that these medicines can bring.

Lisa Skeens, Ph.D., global vice president for regulatory affairs for the company, explained that different nonproprietary names for a biologic and the biosimilar medicine patterned on that biologic 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.

Hospira is not alone in this fight.

According to an article on, the European Biosimilars Group, part of the European Generic Medicines Association are also concerned with the naming, as well as the WHO's porposed biological qualifier system.

"The more elements physicians and pharmacists have to record, and the more complex these elemnts are, the higher likelihood, something will get left out," Joerg Windisch, chair of the European Biosimilars Group and Chief Science Officer at Sandoz Biopharmaceuticals, told the WHO, according to the article.

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