Online consultation on biological drug naming in Canada

Generics and biosimilars Initiative

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Online consultation on biological drug naming in Canada

INICIO/Políticas y legislación | Posted 19/04/2019 0 Post your comment

Health Canada and the Institute for Safe Medication Practices Canada conducted an online consultation on the naming of biological drugs in 2018.

The consultation proposed three options for the naming of biological drugs (including biosimilars). For all three options, all biological drugs will continue to have a unique Drug Identification Number (DIN).

Option 1: Continue the current Canadian drug identification and naming approach [status quo]. Biosimilars, reference biologicals, and innovator biologicals that share the same non-proprietary name can be distinguished by their unique brand name or DIN, however, in some settings only the non-proprietary name is used.

Option 2: Use of the brand name with the non-proprietary name to distinguish among biologicals. Both brand and non-proprietary names would be used, so biosimilars, reference biologicals, and innovator biologicals that share the same non-proprietary name would be distinguished by their unique brand names.

Option 3: Implement a four-letter suffix appended to the non-proprietary name. All biological drugs, including biosimilars, reference biologicals and innovator biologicals, would receive a unique, meaningless four-letter suffix appended to the non-proprietary name. Products sharing the same non-proprietary name would be distinguished by the suffix. Guidelines would be developed to align with the US Food and Drug Administration’s (FDA) suffix-based naming convention as much as possible [1].

Of the 362 respondents to the online consultation, 79% were healthcare providers, with pharmacists and pharmacy-related organisations representing 62% of respondents. Responses were also received from pharmaceutical manufacturers, insurers, consumers and organisations representing consumers, information technology providers, as well as other organisations such as advocacy and educational groups.

Respondents’ comments were diverse. In general, they were supportive of change from the status quo with 70% of respondents indicating that the current Canadian drug identification and naming approach was not acceptable. Option 2 was the most favoured and highest ranked naming option, with 75% of respondents rating it as preferred or acceptable, and 75% indicating that it is compatible with their current practice or environment. Option 3 was the second-ranked naming option, with 51% of respondents rating it as preferred or acceptable and 61% indicating that it is compatible with their current practice or environment.
This online consultation was conducted following widespread concern in the US that the FDA’s finalized naming guidelines for biologicals are an obstacle to the use of biosimilars [2].

Key considerations for biosimilars in the US

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. Naming is an obstacle to the use of biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Biosimilars/Research/Naming-is-an-obstacle-to-the-use-of-biosimilars-in-the-US

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Source: Health Canada