Biosimilar biologics

What are biologics

Over the past 22 years in Canada, biologics have become a life-saving treatment option for inflammatory arthritis patients whose disease does not respond, or respond well enough, to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) such as hydroxychloroquine or sulfasalazine. Biologics are proven to effectively address disease signs and symptoms – like swelling, pain. and fatigue – but also may improve mortality and reduce heart disease and other complications of inflammatory arthritis.

Biologics are made from living organisms like yeast and bacteria. The first version of a biologic developed is known as the “originator.” This is because they are the original version of a drug that a biosimilar is based on. Biologics are much larger and more complex in nature than conventional, small molecule medicines such as over-the-counter ibuprofen (e.g., Advil) or by-prescription methotrexate. Biologics are administered in two ways; by self-injection under the skin or into muscle, or by intravenous (IV) infusion into a vein in the hand, wrist or arm.

Because of their complexity, biologics are expensive and time consuming to develop. This can make it difficult for the healthcare system to afford them and limit patients’ access to biologics. According to data from the Canadian Institute for Health Information, public drug program spending on biologic medicines reached $4.4 billion in 2021 (29% of total public drug program spending). And for the tenth consecutive year, anti-TNF biologic medicines used for rheumatoid arthritis and Crohn’s disease accounted for the highest proportion of that public drug spending total.1

What are biosimilar biologics?

When the patent of an originator expires, other manufacturers are allowed to make a biosimilar version of the medicine. A biosimilar has similar effectiveness, safety, and quality and delivers the same therapeutic benefits to patients as its originator.2

Biosimilars are typically prescribed to inflammatory arthritis patients by a rheumatologist. For example:
  • Adalimumab (Abrilada®), adalimumab (Amgevita®), adalimumab (Hadlima®), adalimumab (Hulio®), adalimumab (Hyrimoz®) and adalimumab (Idacio®), adalimumab (Simlandi®), and adalimumab (Yuflyma®) are biosimilar versions of the originator adalimumab (Humira®);
  • etanercept (Brenzys®) and etanercept (Erelzi®) are biosimilar versions of the originator etanercept (Enbrel®);
  • infliximab (Avsola®), infliximab (Inflectra®) and infliximab (Renflexis®) are biosimilar versions of the originator infliximab (Remicade®);
  • rituximab (Riabni®), rituximab (Riximyo®), rituximab (Ruxience®) and rituximab (Truxima®) are biosimilar versions of the originator rituximab (Rituxan®).
Because biosimilars are produced post-patent after originator biologics have already set the foundation of research and development, biosimilar manufacturers do not have the same costs to bring the product to market and can therefore offer it at a lower price.3 The potential savings generated by biosimilars may be reinvested into health care resources needed by Canadian patients.

Biosimilars have been approved for use in Canada since 2009, and in arthritis since 2014. Fifty-two biosimilars are currently approved by Health Canada for chronic diseases, including inflammatory arthritis, cancer, inflammatory bowel disease, diabetes, and psoriasis.

How do patients and healthcare systems benefit from biosimilar biologics?

Biosimilars can be used for the same therapeutic aim as their originator and offer an opportunity to reduce spending on more costly originators. Biosimilars create three main benefits to patients, the healthcare system, and society:
  1. Savings from biosimilars use can modernize “special access criteria.” Currently, patients must try and fail treatment on older, less expensive medications. Because biosimilars are significantly less expensive, public and private drug plans can remove the need for patients to fail on these older therapies before approving reimbursement for biosimilars;
  2. Savings from biosimilars use can be reinvested into public and private drug plan budgets making it possible to improve the sustainability of their drug plans by adding new medication listings and boosting existing medicine coverage for patients; and,
  3. Savings from biosimilars can be invested into non-medication elements of care that patients need, such as specialized nursing, counselling, physiotherapy, and occupational therapy.
The Canadian Government’s Patented Medicine Prices Review Board has estimated that private and public drug plans across Canada could save from $332 million to $1.81 billion in the third year following biosimilar entry across a portfolio of products.4

To learn more about biosimilars, visit the following resources: References
1Canadian Institute for Health Information. Prescribed Drug Spending in Canada, 2021. Ottawa, ON: CIHI; 2022. Infographic
2Health Canada Fact Sheet on Biosimilars
3Canadian Agency for Drugs and Technologies in Health (CADTH): Biosimilar Drugs: Your Questions Answered
4Patented Medicines Prices Review Board. Potential Savings from Biosimilars in Canada. Date modified: 2018-02-05