Handbook for health care professionals on biosimilar biologic drugs: Authorization of biosimilars
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Regulatory authorization
In contrast to generic drugs, Health Canada's authorization of a biosimilar is not a declaration of equivalence to the reference biologic drug.
As for all biologic drugs, once a biosimilar is authorized for sale it receives:
- a notice of compliance (NOC)
- a unique drug identification number (DIN)
- an authorized product monograph (PM)
How Canada compares to international regulatory approaches
The key principles that Canada uses to evaluate biosimilars align with those of other regulators and international organizations, such as the:
- World Health Organization (WHO)
- European Medicines Agency (EMA)
- United States Food and Drug Administration (FDA)
Health Canada works closely with our international counterparts and participates in several initiatives aimed at:
- harmonizing approaches to the regulation of biosimilars internationally
- sharing information on regulatory issues and the authorization of specific product types
Our position on the use of biosimilars is also consistent with the International Coalition of Medicines Regulatory Authorities (ICMRA). The coalition includes key international regulatory partners from:
- the European Union (EU)
- the United States (US)
- the United Kingdom (UK)
- Japan
- Australia