Health Canada has previously conducted stakeholder consultations and analysis of issues relating to the naming of biologic drugs, including biosimilars (for further details please see "Stakeholder consultation on naming of biologic drugs, including biosimilars"). On 14 February 2019 Health Canada announced its Policy Statement on the Naming of Biologic Drugs, which states that "biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix". This policy is currently used in the United States.
Further, both brand and non-proprietary names should be used throughout the medication use process to allow biologics that share the same non-proprietary name to be distinguished by their unique brand names. To implement this naming convention, Health Canada will:
- update related guidance and amend the regulations;
- communicate with stakeholders on the importance of recording both brand and non-proprietary names throughout the medication use process; and
- undertake activities to assist pharmacovigilance, including updating alternative dispute resolution reporting forms.
Health Canada also published a "What We Heard Report" which summarised stakeholder comments that were made during the consultation.
For further information on this topic please contact Urszula Wojtyra at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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