Biosimilars are biologic medicines that aim to provide similar therapeutic effects to an original biologic medicine that has already been authorized for sale by Health Canada and prescribed by Canadian healthcare professionals for some time.
As originator biologic medicine patents expire, more biosimilars will come to market, which in turn will create more treatment options for patients and their doctors. Unlike generic pharmaceuticals, biosimilars are not exact copies of their originator biologic medicine.
In order to be authorized for sale in Canada, Health Canada demands that manufacturers of biosimilars demonstrate that their medicines are highly similar to a reference biologic, or originator biologic, that has already been authorized for sale in Canada. This is done through an array of testing — in the lab and in clinical trials — to demonstrate similarity in a number of ways.
Health Canada will provide authorization based on a combination of evidence demonstrated from these various lab tests and from clinical trial results.
“These are exciting times, and oncologists will enthusiastically incorporate these new products into our armamentarium so long as steps are taken to ensure that this does not compromise our patients’ safety. Patients should be kept fully informed about their medication and should be consulted if any changes to their treatment are made.” – Sandeep Sehdev, MD, FRCP, Medical Oncologist, William Osler Health System
All of this means that biosimilars are held to very high standards to ensure that they provide similar therapeutic offerings. Doctors and patients can be sure that biosimilars, like their reference biologic counterparts, have been manufactured using the same type of expertise, the same kinds of high-end equipment and facilities, and the same level of testing and precision.
Like all medicines, biosimilars can cause certain side effects, depending on the particular therapy. Potential adverse events can range from injection site reactions, to nausea and headaches, to serious infections such as sepsis or tuberculosis, among others. The risks and benefits of treatment with a biologic are detailed in its product monograph, and should always be considered prior to initiating therapy.
Find out why it’s so important for biosimilars to be distinguishable from their originator biologic by reading The Importance of Naming Biologic Medicines.
- Health Canada. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs). Accessed: June 9, 2016.