New drugs entering Canada at steady rate over past 5 years

News release

February 10, 2021 — Ottawa, ON — Patented Medicine Prices Review Board

The latest edition of the Patented Medicine Prices Review Board (PMPRB) Meds Entry Watch reports that 40 new-to-Canada medicines were approved for market in 2018, of which 22 had reported sales by the end of 2019. This is in line with the annual rate of approximately nine new approvals per quarter since 2015, a trend that continued steadily into 2019.

Internationally, 51 new drugs were first approved in the US, Europe, and Canada in 2018, of which more than two thirds were high-cost and over 60% were treatments for rare diseases. Four of the five top-selling new medicines were approved in Canada in the same year, including the antiviral drug bictegravir (Biktarvy), which alone accounted for over half of total sales for the 51 new medicines by the end of 2019.  

This report, produced through the National Prescription Drug Utilization Information System (NPDUIS) research initiative, is the fifth edition in the annual Meds Entry Watch series, which provides the latest information on new medicines entering Canadian and international markets.

Quick facts

  • In 2018, Health Canada approved 40 new-to-Canada medicines, of which 22 had reported sales by Q4-2019, accounting for 1.6% of the total Canadian pharmaceutical market. On average, international prices for these medicines were 19% lower than the prices paid by Canadians. 

  • 51 new medicines were approved internationally in 2018, of which over 60% had an orphan designation from the FDA and/or the EMA while more than 30% were indicated for the treatment of cancer. 

  •  Health Canada had approved 20 of the 51 new medicines by the end of 2019, of which nine had recorded sales in Canada, placing Canada ninth in the OECD and in line with the PMPRB11 comparator countries, most of which have lower average patented medicine prices.

  • Over two thirds of the new medicines approved in 2018 were high-cost: 13 oncology medicines had costs exceeding $5,000 per 28-day cycle and 21 non-oncology medicines had annual costs exceeding $10,000. 

  • Of the total new medicines approved internationally between 2015 and 2018, 38% had Canadian sales by the end of 2019. This group of medicines accounted for 87% of all new medicine sales in the OECD in Q4-2019, indicating that the higher-selling medicines continue to be among those approved and sold in Canada.

  • 47 new medicines received market authorization in 2019, of which 16 were approved in Canada by Q3-2020. In total, 40% (19) of the 2019 new medicines were orphan-designated while just under a quarter were oncology treatments.  

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