Biosimilars in Canada: Policies to Promote Switching and What It Means for Payers

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Presentation to the 2025 Annual CAHSPR Conference May 2025

Presented by: Yvonne Zhang, Senior Economist
NPDUIS Research Initiative, Patented Medicine Prices Review Board

Disclosure: I have no actual or potential conflict of interest in relation to this topic or presentation.

Background and Objectives

Potential savings from biosimilars are a topic of international interest with relevance for Canada.
Given Canada’s high-use, high-cost biologics market, increased biosimilar adoption offers a significant opportunity for cost savings for Canadian payers.
This presentation compares the evolving Canadian market for biosimilars with international counterparts.
The analysis focuses on biosimilar market dynamics in Canada, assessing the impact of biosimilar switching to date and the potential for further cost savings.

Data Sources and Limitations

This study is part of the PMPRB’s broader reporting in the Biologics in Canada chartbook series.
Data sources:
- IQVIA’s MIDAS® Database (2014–2023); US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada (HC) databases:
  - for international comparisons of biosimilar availability, uptake, and sales.
- IQVIA’s Canadian Drugstore and Hospital Purchases Audit (CDH, 2019–2023):
  - for Canadian biosimilar uptake and savings potential.
Limitations:
- Biologic medicines were selected based on Health Canada’s Drug Product Database (DPD) Schedule D and Prescription lists and include insulin biologics.
- The cost savings model does not explore the impact of policy changes on biosimilar price levels; prices of biosimilars in the study period were used to calculate cost implications and savings.

Overview

Biologics market trends in Canada and international comparisons
Biosimilar availability and uptake in Canada and other OECD countries
Biosimilar uptake challenges and current policies in Canada
Cost-saving opportunities from biosimilars

Biologic medicine sales tripled over the last decade

Sales of biologic medicines in Canada, 2014 to 2023

Figure - Text version

Sales growth, 2022 to 2023: 19.9%

5-year compound annual growth rate: 14.5%

10- year compound annual growth rate: 12.9%

	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023
Sales in billions of dollars	$4.9	$5.4	$6.0	$6.7	$7.7	$8.7	$10.0	$11.1	$12.5	$15.0
Biologic share of pharmaceutical sales	24.1%	24.7%	25.9%	27.5%	30.1%	32.2%	33.9%	34.8%	35.6%	38.6%
Biologic sales per capita	$141	$153	$167	$185	$208	$233	$262	$290	$322	$381

Note: Includes all prescription biologics as per Health Canada’s Drug Product Database (DPD) Schedule D and Prescription lists, as well as insulin biologics.
Data source: IQVIA MIDAS® Database. All rights reserved.

Sales of biologic medicines in Canada tripled from $4.9B in 2014 to $15.0B in 2023.
This represents a 10-year compound annual growth rate of 12.9%.
In 2023 alone, biologics sales increased by 19.9%.

Canada placed among the top-ranked countries in the OECD for biologics spending

Biologic share of total sales and sales per capita, OECD*, 2023

Figure - Text version

Country	Biologic share of sales as a percentage	Biologic sales per capita in Canadian dollars
US	41.5%	$1,176
Canada	38.6%	$381
Belgium	38.0%	$331
Australia	37.5%	$210
Ireland	36.5%	$273
France	35.8%	$301
Switzerland	34.9%	$393
Austria	33.5%	$321
Slovenia	32.7%	$187
Sweden	32.7%	$210
Norway	32.7%	$272
Germany	30.3%	$252
Spain	30.1%	$263
Finland	29.6%	$206
Czechia	29.1%	$155
United Kingdom	28.5%	$205
Hungary	28.4%	$112
Italy	27.9%	$245
Slovakia	27.4%	$118
New Zealand	24.4%	$74
Poland	23.2%	$75
Portugal	21.9%	$136
Japan	19.4%	$134
Turkïye	15.4%	$23
South Korea	12.7%	$55
OECD median	30.1%	$210

Note: Includes all prescription biologics as per Health Canada’s Drug Product
Database (DPD) Schedule D and Prescription lists, as well as insulin biologics.
Data source: IQVIA MIDAS® Database. All rights reserved.

* Six OECD countries with incomplete biologic sales data in 2023 were excluded from the figure.

Biologics accounted for 38.6% of total pharmaceutical sales in Canada in 2023, a higher share than the OECD median of 30.1%.
Per capita spending on biologics was $381, 80% more than the OECD median of $210, placing Canada second to the U.S.

Biosimilar availability and sales in Canada close to EU and exceed U.S.

Number of medicines* with biosimilars approved in Europe, the US, or Canada, as of 2023

Biologic Medicine	EMA (n=22)	FDA (n=15)	Health Canada (n=18)
Adalimumab	✔	✔	✔
Aflibercept	✔
Bevacizumab	✔	✔	✔
Eculizumab	✔
Enoxaparin sodium	✔		✔
Epoetin alfa	✔	✔
Epoetin zeta	✔
Etanercept	✔	✔	✔
Filgrastim	✔	✔	✔
Follitropin alfa	✔
Human insulin			✔
Infliximab	✔	✔	✔
Insulin aspart	✔		✔
Insulin glargine	✔	✔	✔
Insulin lispro	✔		✔
Natalizumab	✔	✔
Pegfilgrastim	✔	✔	✔
Ranibizumab	✔	✔	✔
Rituximab	✔	✔	✔
Somatropin	✔	✔	✔
Teriparatide	✔		✔
Tocilizumab	✔	✔	✔
Trastuzumab	✔	✔	✔
Ustekinumab		✔	✔
% Biosimilar sales of overall biologics, 2023	14.2%	3.2%	11.8%

* Multiple biosimilar trade names referencing the same originator biologic are counted as one biosimilar medicine.

Data source: US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada databases;
IQVIA MIDAS® Database, prescription retail and hospital markets, All rights reserved.

As of 2023, biosimilars were approved for 18 biologic medicines in Canada, compared to 22 in the EU and 15 in the U.S.
Biosimilars accounted for 12% of total biologic sales in Canada, close to 14% in the EU and ahead of 3% in the U.S.
Availability and market share of biosimilars in Canada have kept pace with Europe, despite fewer approvals.

Canada’s biosimilar uptake kept pace with the OECD trends

Figure - Text version

Biologic medicine	Sales in Canada, in millions of dollars, 2023	Biosimilar uptake as a share of units, fourth quarter of 2023, Canada	Biosimilar uptake as a share of units, fourth quarter of 2023, OECD median
Infliximab	$1,214	59%	87%
Adalimumab	$900	72%	56%
Etanercept	$234	78%	47%
Rituximab	$221	48%	79%
Ranibizumab‡	$221	28%	18%
Insulin glargine	$200	51%	18%
Trastuzumab‡	$140	90%	52%
Epoetin alfa*	$121	n/a	90%
Pegfilgrastim*	$117	99%	87%
Bevacizumab‡	$102	94%	94%
Insulin aspart	$89	47%	8%
Filgrastim*	$88	92%	97%
Insulin lispro	$86	42%	20%
Enoxaparin sodium	$50	60%	46%
Somatropin	$44	24%	35%
Follitropin alfa*	$25	n/a	35%
Teriparatide	$8	73%	76%

*Generally used on a short-term basis.
‡ Mainly indicated in oncology or ophthalmology.
Administered in hospitals or clinic setting in Canada.
† Canada is excluded from the median.

Canada achieved biosimilar uptake similar to or above that of the OECD median for most high-selling biologics.
Infliximab, the highest-selling biologic, had a 59% biosimilar share in Canada in 2023, below the OECD median of 87%.
Adalimumab, another high-selling biologic medicine, had a 72% biosimilar uptake in Canada in 2023, higher than the OECD median of 56%.

Uptake of biosimilars in Canada has increased following switching initiatives, led by BC

Figure - Text version

Canada						British Columbia
Biosimilar uptake by year and month		Infliximab	Etanercept	Adalimumab		Biosimilar uptake by year and month		Infliximab	Etanercept	Adalimumab
2019	Jan	7%	11%	-	-	2019	Jan	13%	15%	-
	Feb	8%	12%	-	-		Feb	15%	16%	-
	Mar	8%	12%	-	-		Mar	16%	15%	-
	Apr	9%	13%	-	-		Apr	14%	18%	-
	May	9%	13%	-	-		May	15%	18%	-
	Jun	9%	14%	-	-		Jun	18%	24%	-
	Jul	10%	16%	-	-		Jul	20%	30%	-
	Aug	9%	18%	-	-		Aug	19%	39%	-
	Sep	9%	19%	-	-		Sep	22%	51%	-
	Oct	11%	22%	-	-		Oct	30%	61%	-
	Nov	13%	25%	-	-		Nov	44%	73%	-
	Dec	11%	25%	-	-		Dec	45%	87%	-
2020	Jan	13%	28%	-	-	2020	Jan	73%	90%	-
	Feb	15%	28%	-	-		Feb	81%	90%	-
	Mar	17%	29%	-	-		Mar	86%	89%	-
	Apr	18%	31%	-	-		Apr	88%	91%	-
	May	19%	31%	-	-		May	92%	90%	-
	Jun	21%	32%	-	-		Jun	92%	89%	-
	Jul	20%	31%	-	-		Jul	92%	87%	-
	Aug	20%	33%	-	-		Aug	91%	88%	-
	Sep	21%	34%	-	-		Sep	92%	89%	-
	Oct	21%	35%	-	-		Oct	91%	88%	-
	Nov	20%	36%	-	-		Nov	91%	88%	-
	Dec	21%	33%	-	-		Dec	92%	87%	-
2021	Jan	24%	37%	0%	-	2021	Jan	92%	88%	0%
	Feb	23%	38%	0.1%	-		Feb	90%	88%	0.2%
	Mar	23%	38%	3%	-		Mar	90%	87%	4%
	Apr	19%	38%	1%	-		Apr	88%	87%	2%
	May	23%	40%	3%	-		May	91%	88%	9%
	Jun	25%	40%	5%	-		Jun	92%	88%	22%
	Jul	26%	41%	8%	-		Jul	93%	86%	34%
	Aug	25%	41%	11%	-		Aug	92%	87%	48%
	Sep	25%	42%	14%	-		Sep	92%	87%	63%
	Oct	27%	43%	19%	-		Oct	93%	88%	84%
	Nov	26%	48%	22%	-		Nov	91%	91%	92%
	Dec	29%	48%	25%	-		Dec	94%	89%	92%
2022	Jan	31%	50%	26%	-	2022	Jan	89%	89%	92%
	Feb	31%	54%	30%	-		Feb	91%	90%	92%
	Mar	38%	54%	35%	-		Mar	91%	89%	91%
	Apr	40%	58%	42%	-		Apr	90%	89%	92%
	May	43%	62%	48%	-		May	91%	91%	92%
	Jun	42%	61%	51%	-		Jun	92%	90%	93%
	Jul	43%	63%	53%	-		Jul	90%	90%	93%
	Aug	44%	63%	51%	-		Aug	89%	89%	93%
	Sep	45%	64%	53%	-		Sep	90%	89%	93%
	Oct	43%	64%	54%	-		Oct	89%	88%	93%
	Nov	45%	65%	54%	-		Nov	93%	88%	93%
	Dec	46%	64%	57%	-		Dec	90%	90%	93%
2023	Jan	45%	66%	56%	-	2023	Jan	92%	88%	93%
	Feb	47%	69%	58%	-		Feb	94%	90%	91%
	Mar	47%	69%	60%	-		Mar	93%	90%	90%
	Apr	50%	70%	61%	-		Apr	94%	87%	91%
	May	51%	71%	63%	-		May	92%	89%	91%
	Jun	49%	74%	65%	-		Jun	93%	88%	91%
	Jul	56%	75%	66%	-		Jul	94%	87%	91%
	Aug	55%	76%	67%	-		Aug	95%	88%	91%
	Sep	54%	76%	68%	-		Sep	94%	87%	90%
	Oct	57%	77%	70%	-		Oct	94%	86%	90%
	Nov	59%	79%	71%	-		Nov	93%	87%	90%
	Dec	61%	80%	73%	-		Dec	94%	88%	91%

Since May 2019, Canadian payers have launched switching initiatives to increase uptake, led by British Columbia (BC).
Biosimilars for three widely used anti-TNF-α drugs (adalimumab, infliximab, and etanercept) reached ~90% market share in BC between mid-2020 and late 2021.
National uptake for these medicines gradually rose to 60– 80% of units sold by December 2023.

Growing biosimilar savings in Canada, with more to gain

Realized and potential savings from biosimilar use in Canada, 2020 to 2023

Figure - Text version

Year	Realized savings from biosimilar use in Canada, in millions of dollars	Unrealized potential savings from biosimilar use in Canada, in millions of dollars	Potential savings from biosimilar use in Canada	Realized share of savings from biosimilar use in Canada	Unrealized potential share savings from biosimilar use in Canada as a share
2020	$152	$516	$669	23%	77%
2021	$250	$628	$878	28%	72%
2022	$527	$602	$1,128	47%	53%
2023	$777	$480	$1,257	62%	38%

Biologic medicine	Total potential savings, 2020 to 2023
Biologic medicine	Estimated actual savings	Unrealized savings	Total
Infliximab	$ 971.8M	$ 1,606.9M	$ 2,578.7M
Etanercept	$ 220.1M	$ 177.4M	$ 397.6M
Adalimumab	$ 514.0M	$ 441.1M	$ 955.0M
Savings	$ 1,705.9M	$ 2,225.4M	$ 3,931.3M

Biosimilar use for three high-selling biologics — infliximab, adalimumab, and etanercept, generated $1.7B in savings between 2020 and 2023.
If uptake across Canada had matched the higher uptake levels in British Columbia, an additional $2.2B in savings could have been realized.
Biosimilar uptake has increased over time, with the realized share of potential savings growing from 23% in 2020 to 62% in 2023.

Conclusions

Biologics are a high-growth market in Canada, with sales tripling over the last decade.
Biosimilar availability and market share in Canada have kept pace with Europe.
Biosimilars uptake for high-selling products aligns with the OECD trends.
Biosimilar switching is led by provinces and payers, resulting in varied uptake across jurisdictions.
With nearly 40% in savings still unrealized, broader adoption of switching initiatives could further reduce drug spending.

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Date modified:: 2025-06-26

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Biosimilars in Canada: Policies to Promote Switching and What It Means for Payers

Background and Objectives

Data Sources and Limitations

Overview

Biologic medicine sales tripled over the last decade

Canada placed among the top-ranked countries in the OECD for biologics spending

Biosimilar availability and sales in Canada close to EU and exceed U.S.

Canada’s biosimilar uptake kept pace with the OECD trends

Uptake of biosimilars in Canada has increased following switching initiatives, led by BC

Growing biosimilar savings in Canada, with more to gain

Conclusions

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