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Safety and monitoring of biosimilars

Regulation of biosimilar drugs in Canada

Biosimilar drugs are regulated in the same way as new drugs. As with all drugs, Health Canada's decision to authorize a biosimilar drug for sale or not is based on a benefit/risk assessment, after considering all the data provided by the manufacturer.

Health Canada's rigorous standards for authorization mean that patients and health care providers can have the same confidence in the quality, efficacy and safety of a biosimilar drug as in reference biologic drugs.

For a drug to be considered a biosimilar drug, the manufacturer must demonstrate to Health Canada that its drug and the reference biologic drug are very similar. They must also prove that there are no meaningful medical differences between them in terms of safety and efficacy.


Biosimilar drugs are as safe as reference biologics and work the same way. No meaningful differences have been observed between a biosimilar drug and its reference biologic drug.

Several learned societies, such as the World Health Organization This hyperlink will open in a new window., have expressed support for biosimilar drugs in their respective fields.

As with all drugs, there is always a risk of adverse reactions. If you suspect you are having an adverse reaction to the drug you are taking, contact your healthcare team.


Both Health Canada and drug manufacturers play a role in monitoring the safety of drugs on the market, including biosimilar drugs.

Health Canada:

  • Monitors adverse reaction reports
  • Investigates complaints and problem reports
  • Conducts market surveillance


  • Report any new information received about serious adverse reactions to Health Canada
  • Monitor adverse reactions reported
  • Notify Health Canada about any studies with new safety information
  • Request authorizations for any major changes to the manufacturing process, dose regimen or recommended use of the drug

Health Canada receives information on these drugs from other administrations, including the United States and the European Union. Biosimilar drugs have been used for more than 10 years in the European Union and no abnormal or unexpected effects have been reported.

See Health Canada's site on biosimilars This hyperlink will open in a new window..

Last update: May 18, 2021


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