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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 a patent was filed), other manufacturers can bring biosimilars on to 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. In fact, 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. 
  • There are currently 17 biosimilar products approved for sale in Canada; 23 in the United States and 54 in the European Union.
What other countries are doing with biosimilars

The Patented Medicines Price Review Board 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%
  • UK: 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 the Patented Medicines Price Review Board, seven of the top-10 selling drugs in Canada in 2016 were biologics. In addition, there are 13 biologics that have expired patents – or patents that will expire – by 2020. This will allow manufacturers to submit biosimilars for market authorization. Since there is a much higher use of biologics in Canada, it means that Canadians have the most to gain from biosimilar savings. Source:
  • 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. Source:
  • In addition, as of September 2018, there are seven biosimilars available in Canada, and their uptake has been modest. For example, infliximab and etanercept biosimilars accounted for 2.4% of claims and 1.4% of spending in 2017. Source:
  • 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. Source: