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Key Facts

About Biosimilars and Switching

Biosimilars represent an enormous opportunity to enhance patient care and improve the sustainability of Canadian health systems.

Patients should know the important facts:

1. Biosimilars are safe and effective medicines that treat diseases like cancer, diabetes, arthritis and inflammatory bowel disease.
Biosimilars are biologic medicines that have been approved by Health Canada after a rigorous and evidence-based review process. Every biosimilar must demonstrate its similarity to another biologic medicine that is already available in the Canadian marketplace and no longer protected by a patent.  As Health Canada says: “Our rigorous standards for authorization mean that you can have the same confidence in the quality, efficacy and safety of a biosimilar as in any other biologic drug.”

2. Patients can expect no difference in efficacy and safety following a routine switch to a biosimilar.
Health Canada says that “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.” Health Canada has also been quoted as saying that it has no concerns about the switching policy implemented by the B.C. government.

3. A well-controlled switch policy protects patient choice.
In a well-controlled switch, a patient has a conversation with their physician about switching to a biosimilar. When a patient switches to a biosimilar, they are switching from one manufacturer’s version of a biologic medicine to another manufacturer’s version of that biologic medicine. As a result, under a well-controlled switch policy, patients do not lose access to any therapeutic option. Under B.C.’s Biosimilars Initiative, prescribers may request coverage of the reference biologic in those exceptional circumstances where switching may not be appropriate for medical reasons.

4. Biosimilars could deliver over a Billion dollars in savings per year to the Canadian health care system.
The Government of Canada’s Patented Medicines Pricing Review Board (PMPRB) estimated that drug plans across Canada could save from $332M to $1.81B in the 3rd year following biosimilar entry across a portfolio of products.  To fully access these savings, governments need to introduce the appropriate policies, including implementing a well-controlled switch policy.

5. Governments can use the savings from biosimilars to provide more patients with access to more treatments.
Following the introduction of lower-priced biosimilar medicines, many provincial governments across Canada have changed their coverage to allow new groups of patients to access these medicines.  When B.C. implemented its switching policy, the government committed to using the savings to provide access to new drugs, to expand access to existing drugs, to fund more nursing support, and to provide full coverage for a new diagnostic test.