Health Canada Forgoes Suffixes in Naming of Biologic Drugs

February 26, 2019

Biosimilars Team

In almost direct contrast to the biosimilars naming convention adopted by the U.S. Food and Drug Administration (FDA), Health Canada has announced that biologic drugs (including biosimilars) will be identified by their unique brand name and nonproprietary (common) name, without the addition of a product-specific suffix. Both the brand name and nonproprietary name are to be used throughout the medication use process so that biologics that share the same nonproprietary name can be distinguished by their unique brand names.

Health Canada stated that all biologics (including biosimilars) will continue to have a unique Drug Identification Number (DIN) that distinguishes key characteristics including brand name, manufacturer name, medicinal ingredient(s), strength(s), dosage form, and route of administration. The DIN is used to specifically identify products in Canadian health care system databases; it is analogous to the National Drug Code, or NDC, used in the United States.

Under the naming convention adopted by the FDA, the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product must consist of two parts:

  • A core name that will be the same for all products (e.g., replicamab).
  • A distinguishing suffix that is devoid of meaning and composed of four lowercase letters, separated from the core name by a hyphen (e.g., replicamab-cznm, replicamab-hjxf).

The FDA expects that the distinguishing suffixes will be used routinely when identifying, describing, and recording use of biological products.

The FDA naming convention drew mixed responses when it was first proposed in 2015 and again when it was finalized in 2017. Groups that opposed the convention—including many health care organizations, providers, manufacturers, and patient advocacy groups—expressed concern that meaningless suffixes would contribute to prescribing and dispensing errors and confusion and complicate therapeutic interchange of biologic drugs. They called for biological products to have either (1) common International Nonproprietary Names (INNs) without prefixes or suffixes or (2) at least, suffixes that conveyed useful information. Among the concerns identified by the opposition were the potential for prescribing and dispensing errors and confusion

In explaining its decision to identify biologic drugs by their unique brand name and nonproprietary name, Health Canada cited considerations that included the following:

  • Unique brand names are consistent with current biologics naming practice and are already recognized and in use.
  • Using both brand name and nonproprietary name avoids any potential perception that different suffixes indicate clinically meaningful differences between a biosimilar and its reference biologic drug.
  • An analysis of the Canada Vigilance database shows that reporting by brand name is largely successful in achieving accurate product-level attribution of spontaneously reported adverse events for suspected biologics.

The traceability of biologics primarily used in hospital settings was identified as an area for improvement.