What are biosimilar drugs?

January 8, 2026

To understand biosimilars, we first need to know what biologic drugs are. Biologic drugs are complex medicines made from living organisms to support bodily functions and conditions that can impact daily life. They are used to treat various conditions, including cancer, autoimmune diseases, and chronic illnesses. Some well-known brand name biologic drugs include Humira, Remicade, and Herceptin.

A Biosimilar drug is a biologic drug that is highly similar to an originator biologic drug that has been previously authorized for sale by Health Canada. There are no expected clinically meaningful differences in efficacy and safety between a biosimilar and the originator biologic drug. A biosimilar is developed to enter the market after the patents or data protection rights for an originator biologic have expired. Biosimilars are also made in living cells, so while they are highly similar to their originator biologic, they are not identical. Instead, biosimilars are designed to be as close as possible in terms of structure, function, and effectiveness.

How are biosimilars approved? 

Biosimilars undergo a rigorous approval process to ensure they are as safe and effective as the originator biologic. Health Canada requires extensive testing and clinical trials to demonstrate that there are no meaningful differences between the biosimilar and the reference biologic drug in terms of safety, purity, and potency.  Biosimilar biologic drugs in Canada: Fact Sheet

Why are biosimilars important? 

Biosimilars offer several significant benefits:

1. Cost savings: One of the primary reasons many benefit plans are switching to biosimilars is the potential for substantial cost savings. Biosimilars are less expensive to produce than biologic drugs because the foundation of research and development has already been completed by the manufacturer of the originator biologic. The originator biologic drug is protected by a patent for several years, which allows its manufacturer to recoup research and development costs. Once the patent expires, manufacturers can produce and market biosimilars at a lower cost which can significantly reduce the associated cost of covering these medications for plan members or their dependents who need them, which in turn helps to ensure the sustainability of the OSSTF Benefit Plans.

2. Encouraging competition: The introduction of biosimilars into the market encourages competition, which can drive down prices even further. This competition can also spur innovation as companies strive to improve their products and services  Biosimilars in Canada: Policies to Promote Switching and What It Means …

---

The information in this document is provided by OSSTF Benefits for general information only. OSSTF Benefits endeavours to have all information current and accurate. We make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, or suitability of the information included. All information is subject to change without notice.

---

< Back to News