EGA proposes to maintain the current INN system for biosimilars

October 16, 2014 1:33 PM

During the 59th WHO Consultation on International Non-proprietary Names for Pharmaceutical Substances, EGA made a presentation on biologics naming.


Joerg Windisch, Chief Science Officer at Sandoz Biopharmaceuticals and Chair of the 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). Dr.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, Dr.Windisch highlighted that no additional component is needed in most jurisdictions, including the EU, where 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 authorisation for the medicinal product. Dr. Windisch also highlighted limitations of the proposed design of the BQ (4 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 organisation. 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”.  “Any new identification policy that discriminates against biosimilar medicines will limit patient access to biologics and also impact the realisation of substantial cost-savings for the EU healthcare systems”, he concluded.

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