Market Access in Canada: The Journey So Far
Canada’s healthcare system has made significant strides in integrating biosimilars into the treatment landscape. The rigorous regulatory framework established by Health Canada, a federal department responsible for helping Canadians maintain and improve their health, ensures that biosimilars meet stringent standards of efficacy, safety and quality (chemistry, manufacturing and controls). This has paved the way for many biosimilars to be approved and made available to Canadian patients, including Biocon Biologics products in the therapeutic areas of oncology, diabetes and immunology.
To-date we’ve experienced tremendous strides in the form of regulatory milestones, cost savings and increased switching policies. Health Canada’s endorsement of biosimilars through a clear and science-based regulatory pathway has led to the approval of 57* biosimilars. Additionally, 19 biosimilars are currently under review by the drug regulator.**
Biosimilars have also contributed to significant healthcare savings in Canada. Sales of biologics topped $11 billion in 2021, placing Canada among the top-ranked countries in the Organization for Economic Co-operation and Development (OECD) in terms of per capita spending.*** Considering the widespread use and expenses associated with biologics in Canada, biosimilars present an opportunity for substantial cost savings.
The government notes that funding oncology biosimilars for people starting treatment has led to substantial savings for the healthcare system. In fiscal years 2020/2021, 2021/2022 and 2022/2023, Ontario saved an estimated $53 million, $44 million and $53 million, respectively***. These savings from biosimilars can help increase patient access and lessen the financial burden on the Canadian health care system.
The majority of provinces and territories in Canada have implemented biosimilar switching policies, encouraging the transition from originator biologics to biosimilars, further driving cost savings and health system sustainability and accessibility to treatments. Biocon Biologics and industry partners such as Biosimilars Canada continue to advocate for more predictable switching policies to support effective commercialization and access to treatments for patients and doctors. To-date, the majority of regional governments have implemented switch initiatives for various specific products, with Canada’s largest province, Ontario, recently completing its first initiative with its deadline ending in January 2024.
Indeed, best practices in biosimilars uptake have shown that switching policies are preferable over programs where patients start on a biosimilar biologic for the first time (“new start policies”). This is where we have seen public policy lead the way. The private sector’s drug plans that mimic government plans benefit from automatic switching programs. Non-government plans also have an opportunity to optimize plans with quality products and cost savings that can be utilized in ways that benefit employers, employees and their families. We anticipate the establishment of uniform switching program policies that ensure predictability for patients, doctors, and the budgets of payers and employers upon the implementation at the launch of biosimilars.