Switching from a Biologic to a Biosimilar Drug in Canada
In the past 50 years, biologic medications have revolutionized and transformed the treatment of many disabling and life-threating diseases as Inflammatory Bowel Disease (IBD), diabetes, arthritis, and cancers.
However, biologics are contributing to the rising costs of healthcare, and this may restrict access to these important medicines. Because biologic drugs’ patents have expired, other manufactures are now able to produce these medicines – which are called biosimilars.
What is a Biosimilar?
Biosimilars can help more patients have access to the life-enhancing benefits of biologic treatment.
Biosimilars are drugs made to be extremely similar to a reference biologic. Although biosimilars cannot be exact copies, they must show similar efficacy (“effectiveness”) and safety to be approved by Health Canada. They must also meet the same manufacturing standards. Biosimilar products first entered the Canadian market in 2009, and various biosimilars have been approved by Health Canada in different therapeutic areas since.
More than 178 clinical trials worldwide involving approximately 21,000 switched individuals confirm that switching from an originator biologic drug to a biosimilar biologic drug is not associated with any major efficacy, safety, or immunogenicity issues.
Why is there a change?
Biosimilars treat the same conditions and produce the same effect at a much lower cost. The re-invested savings could be used for the reimbursement for new innovative drugs, and are important in ensuring individuals have access to the essential therapies they need for years to come. Biosimilars are also used extensively in Europe, where countries have had over 15 years of experience with biosimilars.
Biosimilar switching policies have already been implemented by the provincial drug plans in British Columbia, Alberta, Quebec, New Brunswick, Nova Scotia, and the Northwest Territories.