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Health Canada Updates Its Biosimilar Fact Sheet


Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key topics including interchangeability and switching.

Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key topics including interchangeability and switching.

The fact sheet incorporates a decision the Canadian regulator made earlier this year, when it updated its naming convention for biosimilars, deciding 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. Health Canada says that biosimilars are distinguished by their unique brand names and other product-specific identifiers such as the Drug Identification Number (DIN).

Identification of biosimilars and biologics is particularly important for prescribing, dispensing and adverse drug reaction reporting, Health Canada says, adding that as more biosimilars enter the market, there are more products with the same non-proprietary name.

In regard to interchangeability, Health Canada notes that the term typically refers to the ability for a patient to be changed from one drug to another equivalent drug, usually at the pharmacy level, without the intervention of the prescriber. In Canada, the authority to declare 2 products interchangeable rests with each province and territory according to its own rules and regulations, the regulator says, and it is not equivalent to the authorization of a biosimilar.

For biosimilars, Health Canada considers switching between authorized products to refer to a change from routine use of one specific product to routine use of another specific product. Patients and providers “can have confidence that biosimilars are effective and safe for each of their authorized indications,” the fact sheet reads. “No differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication.”

In another part of the fact sheet, Health Canada stresses that it has not observed unexpected post-authorization safety signals for biosimilars, and that the efficacy and safety profiles of approved biosimilars are consistent with those of their originator products. Biosimilars have been used for over 10 years in the European Union, and unexpected safety issues have not been identified, Health Canada says.

Health Canada says it monitors biosimilar safety as it does with all other drugs, by conducting market surveillance, monitoring adverse reaction reports, investigating complaints and problem reports, and taking action as needed. It said that manufacturer responsibilities include:

  • Creating a monitoring system to report side effects
  • Periodically reassessing drug benefits versus risks
  • Reporting any new information about serious side effects to Health Canada
  • Notifying Health Canada about any studies with new safety information
  • Requesting authorization for any major changes to the manufacturing process, the dosage regimen, or the recommended uses of the drug

Health Canada requests that manufacturers submit and maintain a Risk Management Plan (RMP) for all biologics, including biosimilars. RMPs define manufacturer activities to monitor and detect potential safety signals following market authorization. The RMP of a biosimilar generally includes monitoring and risk minimization activities that are similar to those in place for the reference biologic drug.

Earlier this year, Cancer Care Ontario, the cancer advisory organization for the government of Ontario, Canada, released a new patient fact sheet for those starting or switching to biosimilars.

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