Biosimilar Insulins: A Safe and Effective Option for Treating Diabetes
Insulin is a hormone produced by the pancreas. Its role is to regulate the amount of sugar (glucose) in the blood. In people with diabetes, their body either doesn't produce enough insulin or is unable to use the insulin it does produce.
The first insulins used to treat people with type-1 diabetes were extracted from the pancreas of cattle or pigs. Since 1983, insulins have been made in the lab by introducing a synthetic human gene into a bacterium or yeast. This biosynthetic insulin (manufactured by humans) corresponds perfectly to the insulin produced by the human pancreas.
There are now slightly modified versions of biosynthetic insulin, called insulin analogues, which have different durations of action than natural insulin. Thanks to these advances, people with diabetes are now able to manage their disease better.
What are insulin analogues and biosimilar insulins?
Insulin analogues are biosynthetic insulins whose structure has been slightly modified to offer new treatment options. These modifications have helped create insulin analogues that are fast acting, so as to limit the spike in blood sugar after eating. Other insulin analogues offer long-lasting action to help stabilize glycemia over the entire day.
Biosimilar insulin is a highly similar version of a brand-name insulin analogue.
Due to the complex structure and manufacturing process for insulin analogues, it is impossible to make a completely identical version. However, this version known as a "biosimilar" is as safe and effective as the insulin analogue.
Before obtaining marketing authorization, manufacturers of biosimilar insulins must submit data to Health Canada showing that their product is as safe and effective, and that the manufacturing process and post-marketing surveillance comply with the same quality standards as those applicable to the brand-name insulin analogue. For more information on the differences between biologic drugs and their biosimilars, see the article entitled Biosimilar Drugs: Everyone Wins!
Why should you switch to biosimilar insulin?
Biosimilar insulins are tried and tested. While they were introduced in Canada more recently, they have been used in Europe for many years to successfully treat people with type-1 and type-2 diabetes.
Biosimilar insulins offer all the advantages of insulin analogues, at a lower cost for public and private prescription drug insurance plans. As a result, increasing numbers of drug insurance plans in Canada are no longer reimbursing insulin analogues, which is helping promote the shift from insulin analogues to their biosimilar version, where available on the market.
Easing the Transition
To ensure a smooth transition from the insulin analogue to its biosimilar, it is important to have recent glucose data, so you have a clear picture of the situation before making the switch. This means checking that your diabetes is being properly controlled or if the current treatment is causing hypoglycemia, so any adjustments can be made, as needed.
Biosimilar insulins are generally available in the same formats and concentrations as the insulin analogues they are designed to replace. As a result, the dose of biosimilar insulin will, in most cases, be the same as that of the insulin analogue.
However, each product has its own specific injection device, e.g., an insulin pen. It is therefore important you are given the proper instructions for using your new device, since they each have different characteristics. Ask your pharmacist. They will explain how to use it.
Your pharmacists are always there for you.
Whether you are starting a new treatment with a biosimilar insulin or switching products mid-treatment for reasons of reimbursement, your pharmacists are there to answer all your questions. Go ahead and ask them!
Coverage for biologic drugs and their biosimilars varies from one insurer to another and from one province or territory to another. It is therefore important to check the reimbursement conditions for your drug with your insurer.
The information contained herein is provided for informational purposes only and is not intended to provide complete information on the subject matter or to replace the advice of a health professional. This information does not constitute medical consultation, diagnosis or opinion and should not be interpreted as such. Please consult your health care provider if you have any questions about your health, medications or treatment.