E-DRUG: INNs of biologics and biosimilars: consistency must be preserved
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In their joint response to the WHO public consultation, Health Action International (HAI), the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) support the assignment of a ‘biological qualifier’ (BQ) after the International Nonproprietary Name (INN) of glycosylated biosimilars.
The assignment of BQs prevents Drug Regulatory Authorities (DRAs) developing parallel and different systems of naming biosimilars, which would endanger drug name consistency at global level.
The scheme proposed by the WHO will avoid confusion of multiple names for biosimilars. It should however be mandatory, not voluntary, and respected by all Drug Regulatory Agencies worldwide.
More details at http://english.prescrire.org/en/79/207/46302/3765/3303/SubReportDetails.aspx
Christophe Kopp for MiEF, ISDB, HAI
Editor with Prescrire
E-mail: ckopp@prescrire.org