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Ministry of Health

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What are biosimilars?
  • Biosimilars are highly similar versions of bioengineered drugs, known as biologics.
  • Biologics are expensive, injectable drugs made from living organisms (e.g., bacteria or yeast) and are used to treat a growing number of diseases from cancer to chronic conditions including arthritis, diabetes, and Crohn’s and ulcerative colitis.
  • Once patents for biologic drugs expire (20 years after patent was filed), other manufacturers can bring biosimilars onto the Canadian market, in a similar way to generic drug manufacturers.
  • Since biosimilars are based on work done to develop the original biologic drug, they require less research and development.
  • This means the biosimilar can be priced lower than the biologic – anywhere from 25% to 50% less – providing the same health benefits, for better value.
  • Biosimilars are approved for sale just as any other drug. Health Canada will not approve a biosimilar for sale unless it is proven to have no clinically meaningful difference to the patient compared to the original biologic drug.
  • Similarity between biologics and biosimilars is demonstrated using a step-wise approach beginning with structural and functional studies and continuing with human clinical trials and are evaluated to confirm that there are no clinically meaningful differences in safety and efficacy between them. 
What other countries are doing with biosimilars

The Patented Medicines Price Review Board (PMPRB) has provided the following data on 2018 infliximab biosimilar use rates for Organisation for Economic Co-operation and Development countries.

Infliximab treats rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and Crohn’s disease and ulcerative colitis. The legacy or reference biologic is called Remicade and the two biosimilars currently available in Canada are called Inflectra and Renflexis.

  • Norway: 98%
  • Poland: 96%
  • United Kingdom: 92% 
  • Austria: 89%
  • Italy: 79%
  • Sweden: 78%
  • Slovenia: 64%
  • Portugal: 63%
  • France: 60%
  • Czech Republic: 59%
  • Spain: 56%
  • Germany: 53%
  • Ireland: 40%
  • Korea: 37%
  • Slovakia: 36%
  • Belgium: 30%
  • Turkey: 23%
  • Switzerland: 22%
  • Mexico: 17%
  • Finland: 17%
  • Australia: 16%
  • Japan: 9%
  • Canada: 8%
  • United States: 7%
  • Chile: 0%
  • Hungary: 0%
  • New Zealand: 0%

Data source: MIDAS Database, prescription retail and hospital markets, Q4-2018, IQVIA.

Rising cost of biologics
  • According to 2018 data from the Canadian Institute for Health Information, $14.4 billion of prescribed drug spending (42.7%) was financed by the public sector. Biologics used to treat conditions like rheumatoid arthritis and Crohn’s disease accounted for the highest proportion of public drug spending (8.2%) for the sixth consecutive year. Canadians with drug costs of $10,000 or more represented 2% of beneficiaries but accounted for more than one-third of public drug spending in 2017.
  • According to the Canadian Agency for Drugs and Technologies in Health, many of the top selling biologic drugs already have or are expected to have biosimilars enter the market within the next few years. The European experience shows that increased biosimilar competition has not only affected the prices of the directly comparable biosimilars and their reference product, but also of the whole product class.
New additions to PharmaCare formulary

This Biosimilars Initiative is allowing government to add new drugs to the PharmaCare formulary, meaning more people get affordable access to the medications they need. By using biosimilars in B.C., the Province will put about $96.6 million back into health care over the next three years to help fund coverage for more medications.

Recent additions have been made to the PharmaCare formulary under limited coverage. Limited coverage drugs are not generally considered to be first-line therapies or there are more cost-effective alternatives.

To be eligible for coverage of these drugs, the patient must meet criteria pre-defined by PharmaCare. Actual coverage depends on rules of the patient's PharmaCare plan, including any annual deductible requirement.

These recent additions to the formulary since May 2020 include:

  • Mepolizumab line extension for the treatment of asthma –
    Asthma is a common long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction and easily triggered breathing spasms. Symptoms include episodes of wheezing, coughing, chest tightness and shortness of breath.
  • Glecaprevir+pibrentasvir (Maviret) criteria change for the treatment of Hepatitis C. –
    Hepatitis C is a viral infection that causes liver inflammation, sometimes leading to serious liver damage.
  • Sarilumab (Kevzara) for the treatment of rheumatoid arthritis –
    Rheumatoid arthritis is a chronic inflammatory condition that primarily affects a person’s joints. In some people, the condition can damage a wide variety of body systems, including the skin, eyes, lungs, heart and blood vessels.
  • Inhaler coverage changes, including the addition of Trelegy Ellipta for the treatment of chronic obstructive pulmonary disease (COPD) –
    COPD is a type of obstructive lung disease characterized by long-term breathing problems. The main symptoms include shortness of breath and cough. COPD is a progressive disease, meaning it typically worsens over time. Many people have unrecognized COPD and remain undiagnosed.