Health Canada has decided that all biologic drugs, including biosimilars, will be identified by both their unique brand name and non-proprietary (common) name — without the addition of a product-specific suffix. The ability to distinguish between biologics with the same non-proprietary name is important for pharmacovigilance and to minimize inadvertent substitution of drugs that have not been deemed interchangeable.
This policy statement was communicated in a Notice to Stakeholders, which outlines the following steps that Health Canada will take toward implementation:
- Update guidance documents and proceed with a regulatory amendment to ensure that the current practice of sponsors submitting unique brand names for biologics is adequately supported.
- Provide stakeholder communications on the importance of recording both brand and non-proprietary names throughout the medication use process (as well as other product-specific identifiers, such as DIN and lot numbers where appropriate) to help ensure product-specific identification and traceability of biologics.
- Undertake activities to assist pharmacovigilance (e.g., updating reporting forms and associated instructions).
Health Canada’s Notice to Stakeholders was published together with a “What We Heard Report”, which summarised the feedback received during a stakeholder consultation on this topic conducted by Health Canada and the Institute for Safe Medication Practices Canada in early 2018. As we reported, the consultation compared the existing approach (i.e., the optional use of unique brand names or DINs to distinguish between drugs with the same non-proprietary name) to one of two options: either (i) the requirement to always use a unique brand name, which was adopted, or (ii) or the implementation of a four letter suffix for the non-proprietary name of biosimilars, in line with the US approach. Stakeholders were asked to consider the appropriateness and impact of each approach for Canada.
Health Canada’s decision to require the use of unique brand names together with the non-proprietary name is consistent with the preferences of most survey respondents, with 48% of whom indicated it was their preferred response and 27% of whom indicated that it was acceptable.