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.
Related Publications & Articles
-
Federal Court of Appeal restores Minister of Health’s decision to grant RUZURGI NOC despite FIRDAPSE data protection
The Federal Court found that subsection C.08.004.1(3) of the Food and Drug Regulations applied to prevent the Minister from issuing an NOC in view of the data protection granted to FIRDAPSE, a drug co...Read More -
Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices
On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing).Read More -
Certificate of Supplementary Protection filing fee increase effective April 1, 2023
On April 1, 2023, the fee for filing a Certificate of Supplementary Protection (CSP) will increase from $9,952 to $10,152 in accordance with subsection 9(1) of the Certificate of Supplementary Protect...Read More