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Health Canada announces decision on naming of biologic drugs

As previously reported, Health Canada conducted stakeholder consultations and analysis of issues related to the naming of biologic drugs, including biosimilars. On February 14, 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” (currently used in the United States). Further, both the 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: (i) update related guidance/amend the regulations; (ii) communicate with stakeholders on the importance of recording both brand and non-proprietary names throughout the medication use process; and (iii) undertake activities to assist pharmacovigilance, including updating ADR reporting forms. Health Canada also published a “What We Heard Report” summarizing stakeholder comments made during the consultation.