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Biosimilars – What You Need to Know – for Providers

Find answers to potential patient questions about biosimilars in our handout: Discussing Biosimilars with Patients: A Resource for Healthcare Providers.

What are biologics?

What are biosimilars?

How do biosimilars differ from generic drugs?

  • The active ingredients in generic drugs are exactly the same as the brand name drug, while biosimilars are highly similar but not exact copies.
  • The natural variability and more complex manufacturing of biologics does not allow an exact replication of a biologic molecule.

How are biologics and biosimilars manufactured?

  • Since biologics and biosimilars are made inside living cells, every batch of biologics and biosimilars made is slightly different.
  • When a manufacturer makes changes to the process of how a biologic is made, they need to prove that the product is highly similar to the previous product and that there is no adverse impact upon safety or efficacy.

How are biologics and biosimilars regulated in Canada?

Do biosimilars work as well as the reference biologic?

  • Biosimilars have been shown to have no clinically meaningful differences from the reference biologic in properly designed clinical trials. These trials must have a sensitive and homogenous patient population, an appropriate clinical design and useful study endpoints.
  • Biosimilars have been studied in large numbers of patients. As an example, trastuzumab biosimilars have been trialed in 6 independent Phase 3 clinical trials that had at least 500, and as many as 800 patients in each clinical trial.
  • Biosimilars work in the same ways as their reference biologic. It is expected that if a patient is transitioned to, or started on, a biosimilar, they will have the same outcome as if they were treated with the reference biologic.

How are biologics and biosimilars monitored?

Health Canada monitors the safety of all drugs on the market, including biosimilars. Health Canada and manufacturers both play a role in monitoring drug safety.

Health Canada:


What is switching?

What does it mean to extrapolate indications?

Can biologics and biosimilars be used “off-label”?

  • Biologic or biosimilar drugs may be used for indications that were not submitted by the original manufacturer for approval by Health Canada if there is sufficient clinical evidence in the literature.

Is it safe to use a biologic for an indication that has not been approved by Health Canada?

  • Health Canada does not make any safety recommendations for off-label use of approved medications. However, certain medications in Canada (e.g. bevacizumab (Avastin)) are used and provincially funded for indications where there is no Health Canada-approved indication (cervical cancer).
  • In other regions (e.g., Europe) all indications for the reference biologic are extrapolated to the biosimilar.

How will biosimilars impact the health system in Canada?

Have any other jurisdictions successfully implemented biosimilars?

When did oncology biosimilars enter the Canadian market? 

  • The first therapeutic oncology biosimilar received Health Canada Notice of Compliance in 2018, followed by public funding in 2019.

What cancer drugs will have biosimilars?

  • As of February 2020, Health Canada has approved biosimilars for bevacizumab (Avastin), trastuzumab (Herceptin) and rituximab (Rituxan).