Biologic drugs come from living organisms or from their cells and are generally larger and more complex in composition than chemically produced pharmaceutical drugs. A biosimilar is highly similar to a reference biologic that was already authorized for sale; with no expected clinically meaningful differences in efficacy and safety. A biosimilar may enter the market after the expiry of the reference biologic drug's patents and data protection.
Beginning in 2019, jurisdictions began implementing “Non-Medical Biosimilar Switching Policies” in an effort to reduce public drug costs. Under these policies, public payers only provide coverage for biosimilars instead of their reference biologic, resulting in patients having to change to (or begin) a new biosimilar medication.
Transitions can be difficult for these complex patients due to the complicated nature of biologic and biosimilar medications; patients may have experienced therapeutic failures in the past and often require considerable assistance to effectively transition to a new therapy. Changing therapies can also mean a change in patient support services associated with that therapy, which can put a significant burden on patients themselves.
In order to minimize the risks of potential negative consequences to Canadians, we have developed a series of guiding principles, outlining our key beliefs and advocacy position regarding any non-medical biosimilar transition policy implemented by public and/or private payers.