english.prescrire.org > Topics > Advancing healthcare policy > INNs of biologics and biosimilars: consistency must be preserved (9/2014)
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INNs of biologics and biosimilars: consistency must be preserved (September 2014)

Joint response by HAI, ISDB and MiEF to a WHO public consultation. The WHO proposal to assign a "biological qualifier" after the International Nonproprietary Name (INN) of glycosylated biosimilars offers an acceptable solution at global level. Read on...
 

Brussels, 19 September 2014

Joint response by HAI, ISDB and MiEF to a WHO public consultation. The WHO proposal to assign a "biological qualifier" after the International Nonproprietary Name (INN) of glycosylated biosimilars offers an acceptable solution at global level.

> Click here to download the joint response (pdf, 478 Ko)

Response to the WHO public consultation on the draft  "Proposal for Assignment of Biological Qualifiers (BQ)"

Summary:

  • 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 is an acceptable solution in order to prevent Drug Regulatory Authorities (DRAs) developing parallel and different systems of naming biosimilars, which would endanger medicinal product name consistency at a 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.

Health Action International (HAI)
International Society of Drugs Bulletins (ISDB)
Medicines in Europe Forum (MiEF)

©HAI, ISDB, MiEF 19 September 2014

> Click here to download the joint response (pdf, 478 Ko)