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Biocon Biologics  /  Stories  /  Biosimilars Market Access 101 – Navigating the Canadian Landscape

Biosimilars Market Access 101 – Navigating the Canadian Landscape

“At Biocon Biologics, we’re passionate about bringing affordable, high-quality biosimilar treatments to patients across the world. In Canada specifically, a critical step in increasing access to biosimilars involves understanding their journey through market access and working to shape policy for increased adoption.” Rosie Childerhose, Head, Market Access & Pricing, Canada

Let’s explore the current accomplishments and the future targets for biosimilars in Canada, illuminating their role in transforming healthcare.

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.

Where Biosimilars in Canada Are Headed

Through expanded access, education and awareness, policy development and collaboration, there is an exciting future for biosimilars in Canada. One of the main goals is to broaden the availability of biosimilars across all provinces and territories, ensuring that more patients can benefit from these treatments.

Enhancing education efforts among healthcare providers and patients about the benefits and safety of biosimilars is crucial, as it will help in increasing acceptance and confidence in using biosimilars. We must continue to advocate for supportive policies that streamline market access for biosimilars and foster a competitive market environment, ensuring sustainability and innovation. And finally, we need to strengthen collaborations with healthcare professionals, payers, and patient advocacy groups to align on biosimilar adoption strategies and overcome barriers to improve patient outcomes.

At Biocon Biologics, we are driven by an unwavering purpose to enable equitable access to advanced biologic therapies through our high-quality, cost-effective biosimilars. We have commercialized eight biosimilars in global markets for diabetes, oncology and autoimmune diseases. We have a pipeline of 12 assets at various stages of development which will expand our product offerings to other therapeutic areas such as bone health and ophthalmology. Our global experience and dedication to quality, safety and efficacy guide our efforts in Canada. We are actively engaging with regulatory bodies, healthcare providers and the community to support the biosimilar ecosystem’s growth.

“The journey of biosimilars in Canada is a testament to the collaborative efforts of various stakeholders committed to advancing affordable yet high quality healthcare. As we look ahead, Biocon Biologics is excited to be a part of this journey, contributing to the future accomplishments of biosimilars in Canada. Together, we can achieve a future where every patient has access to the treatments they need at a cost that supports the sustainability of our healthcare system.”

Matthew Erick
Chief Commercial Officer, Advanced Markets,
Biocon Biologics Ltd.

Stay tuned for more updates as we continue to navigate the evolving landscape of biosimilars in Canada and beyond.

*As of March 3, 2024

** Drug and health product submissions under review (SUR) – : As of May 30, 2024

***  biosimilars-policies-promote-switching.pdf (

**** Biosimilars Utilization Data – Cancer Care Ontario

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