Generics and Biosimilars Initiative (GaBI) (04/27/2015)

The World Health Organization (WHO) said in its executive summary of its 59th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances that nearly half of the comments on its proposed biological qualifier (BQ) for naming biologicals were positive. Regulators and "institutions" were least in favor of the BQ. However, more support came from industry, academic, and collaborating centers. Patient groups and pricing associations were about two-thirds in favor, and pharmacist associations were generally not in favor. One area of confusion was the purpose of the BQ, such as prescribing or pharmacovigilance. WHO believes that it would be up to the user to decide how a BQ would be best used in a particular jurisdiction. The Generic Pharmaceutical Association argued in a presentation that INN naming should not be changed, as the brand name is the distinguishing factor, and that BQ would not provide additional value. The European Generic medicines Association also noted that any BQ should be applicable to all biologicals, not just biosimilars.

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