Diverging from FDA, Health Canada Announces Suffix-Free Biologic and Biosimilar Naming Convention

Health Canada has announced that all biologics, including biosimilars, will be identified by their brand names and nonproprietary names without the addition of a product-specific suffix. The regulator says that both the brand name and nonproprietary name of any biologic product should be used at all times so that products that share the same nonproprietary name can be differentiated by their brands.

Every biologic will also continue to have a unique Drug Identification Number (DIN) that distinguishes key product information, such as brand name, manufacturer name, strength, ingredients, dosage form, and route of administration. However, DINs will no longer be used as the standard approach to identifying products in Canada.

Health Canada says that the approach will achieve the objective of distinguishing among biologics in prescribing, dispensing, and pharmacovigilance efforts without imposing an undue regulatory burden. The approach also avoid the complexity of implementing a suffix-based convention and the need to retroactively apply suffixes to the names of already-approved products.

The announcement comes after Health Canada and the Institute for Safe Medication Practices launched a February 2018 online consultation to gain stakeholder feedback on naming conventions for biologics. Among the options for naming that were proposed to stakeholders was one in which Health Canada would align with the FDA’s suffix-based naming approach; the US regulator uses 4-letter suffixes, devoid of meaning, that are appended to the nonproprietary names of biosimilars and newly approved biologics.

While the FDA has argued that its naming convention is necessary to allow for biosimilar-specific pharmacovigilance, a number of stakeholders, including prescribers, have asked the FDA to reconsider the approach, saying that a suffix should be memorable if it is to be useful, and that confusion about suffixes may result in misreported adverse events in the FDA’s Adverse Event Reporting System, thereby hindering pharmacovigilance efforts.

In their responses to the consultation, 362 stakeholders, 79% of whom were healthcare providers, were asked to rate their preferred option for naming: remaining with the status quo of using DINs, using brand names plus nonproprietary names, or implementing a suffix. Only 9% preferred the status quo, while 48% preferred using brand and proprietary names, and 34% preferred using a suffix.

In order to implement the new naming convention, Health Canada will now update its guidance documents and proceed with a regulatory amendment that twill ensure that sponsors are adequately supported in submitting unique brand names for their products. The regulator will also provide stakeholder communications on the importance of recording both brand and nonproprietary names throughout the medication use process, and will undertake activities to assist in pharmacovigilance.