Patients – In it together
Biologics have been a treatment option for patients living with disabling and life-threatening chronic diseases over the past 20 years. Today, there are biosimilar versions of original-brand biologics available to people living with these health challenges. To receive Health Canada's authorization for sale, a biosimilar must demonstrate that it is highly similar to a biologic medicine that is already authorized for sale and has no clinically meaningful differences in efficacy and safety compared to the original-brand biologic.6
Biosimilar medicines are not the same as small molecule generic medicines, which contain identical medicinal ingredients to their original-brand products.
Biosimilars and their original-brand biologic medicines can be shown to be highly similar, but not identical. This is because biologic medicines are often large and complex and are made from living cells rather than with chemicals and so are naturally variable.
Compared to generics, more studies are needed for the regulatory authorization of a biosimilar in order to prove that it is highly similar to its original-brand biologic medicine.
Similarity is shown beginning with structural and functional studies and continuing with human clinical studies. Because the purpose of these studies is to demonstrate similarity, the type of data required to support biosimilar approval differs from that required for an original-brand biologic medicine.7 Not requiring as much research and development, biosimilars can be offered at a lower cost with potential savings for healthcare systems.8 The savings generated by biosimilars may be reinvested into healthcare resources for Canadian patients.
When prescribed a biosimilar medicine, patients can rely on the support of their healthcare team as well as on support and education provided by their patient support program.
If you are a patient living with inflammatory arthritis, diabetes, certain types of cancer, inflammatory bowel disease or Crohn’s disease and are interested in learning more about biosimilars, Health Canada offers a fact sheet, including information about safety, efficacy and quality for patients. Public and private drug plans also have biosimilars information specifically for patients on their websites. Patients can also reach out to a patient organization to learn more and ask to speak to a fellow patient who has experience with a biosimilar.
Patients may have many questions about biosimilars. The decision of a treatment option can be life changing and should be based on a discussion between the doctor and patient and consideration of benefits and harms, treatment goals and tolerance for side effects, accessibility of treatment and affordability.
Your doctor or pharmacist will have valuable information about biosimilars. You can also get additional evidence-based information from your provincial drug plan or private health insurer, patient organizations or patient support programs. Patients who feel they understand their treatment option and who understand that there is a support plan in place are likely to achieve better outcomes.
6 Health Canada Biosimilars Fact Sheet
7 Health Canada Biosimilars Fact Sheet
8 Canadian Agency for Drugs and Technologies in Health (CADTH): Biosimilar Drugs: Your Questions Answered