Health Canada announces naming convention for biologicals

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Health Canada announces naming convention for biologicals

INICIO/Políticas y legislación | Posted 26/04/2019 0 Post your comment

Following a number of stakeholder consultations including the 2018 Consultation on the Naming of Biologic Drugs [1], Health Canada has decided that biological drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Under this naming convention, both the brand name and non-proprietary name should be used throughout the medication use process so that biologicals that share the same non-proprietary name can be distinguished by their unique brand names.

All biologicals, including biosimilars, will continue to have a unique Drug Identification Number (DIN). The DIN distinguishes key characteristics of a drug product, including the brand name, manufacturer name, medicinal ingredient(s), strength(s), dosage form, and route of administration.

This naming convention was the most favoured option among respondents to the 2018 Consultation on the Naming of Biologic Drugs. It will serve to achieve the objective of distinguishing among biologicals in prescribing, dispensing and pharmacovigilance in the Canadian context without imposing an unnecessary regulatory burden. In their responses to the 2018 consultation, numerous healthcare stakeholders, including prescribers, pharmacists, patients, and drug information systems providers, indicated that unique brand names play a critical role in distinguishing among biologicals. This naming convention also avoids the complexity associated with implementation of a suffix-based naming convention with retroactive application to previously authorized biologicals.

To implement this naming convention, Health Canada will update related guidance documents and proceed with a regulatory amendment, and communicate with stakeholders on the importance of recording both brand and non-proprietary names throughout the medication use process. Health Canada will also undertake activities to assist pharmacovigilance, including updating adverse drug reaction reporting forms.

Health Canada’s recent decision on naming convention follows recent developments to biological naming guidance in Australia [2] and the US [3, 4].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Online consultation on biological drug naming in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 26]. Available from: www.gabionline.net/Policies-Legislation/Online-consultation-on-biological-drug-naming-in-Canada
2. GaBI Online - Generics and Biosimilars Initiative. Australia’s TGA will keep same names for biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 26]. Available from: www.gabionline.net/Policies-Legislation/Australia-s-TGA-will-keep-same-names-for-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. FDA proposes update to biosimilar naming guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 26]. Available from: www.gabionline.net/Guidelines/FDA-proposes-update-to-biosimilar-naming-guideline
4. 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 26]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals

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Source: Health Canada