European Generic Medicines Association Comments on Biologics Naming System

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 10-22-2014 07:10

During the 59th World Health Organization (WHO) Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, Open Session to Stakeholders, Joerg Windisch, chief science officer at Sandoz Biopharmaceuticals and chair of the European Generic Medicines Association (EGA)-European Biosimilars Group, welcomed the WHO INN Office’s efforts to counteract the proliferation of divergent naming schemes for biologics around the world by proposing a new identifier called the Biological Qualifier (BQ).

Windisch expressed full support on the premise that the proposed BQ system is voluntary, applies to all biological substances, and is applicable retrospectively. In his presentation, he highlighted that no additional component is needed in most jurisdictions, including the European Union (EU), where he said that existing naming systems have worked very well. Furthermore, he stressed that the proposed BQ should not be linked to the active substance manufacturing site(s) but to the company which has the marketing authorization for the medicinal product. He also highlighted limitations of the proposed design of the BQ (four random consonants) as it would be difficult to remember and has the potential to confuse patients and healthcare professionals.

“We suggest that the WHO INN Expert Group generates different options for the BQ, discusses them in a public workshop, and then has the different options user tested with all relevant stakeholders by an independent organization," said.Windisch, in an EGA statement. "In the absence of such a study, a new system of identifiers cannot be supported and should not be implemented," he concluded.

“The EU naming system is a reliable and proven model for the world,” commented Adrian van den Hoven, EGA director general, in a statement. “Any new identification policy that discriminates against biosimilar medicines will limit patient access to biologics and also impact the realization of substantial cost-savings for the EU healthcare systems”, he concluded.

A summary position of the EGA's position on the WHO biologic qualifier proposal may be found here.

Source: EGA


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