Europe is the largest biosimilar market at $18 billion at list prices, 55% larger than the US. Regulators approved a record 44 biosimilars in the EU in 2025, against 26 in the US.
Why this market is moving now
- A large gap remains: biologics with $143 billion of global sales near loss of exclusivity have no biosimilar in development.
- EU approvals hit a record 44 in 2025, well ahead of 26 in the US.
- Denosumab biosimilars are taking share fast, and the originator's Prolia sales fell 45% in the third quarter of 2026.
- Generic drug makers are leaning on biosimilars for growth, with Teva expecting more than $0.8 billion of biosimilar revenue in 2026.
Key figures
Global figures for this market, with the year each one describes. Use Cite to copy a reference to this page.
| Figure | Value | Year | Cite |
|---|---|---|---|
| Biologics with $143 billion of global sales in the year before they lose exclusivity in Europe, 55% of the total, have no biosimilar in development. | 143 USD billion | 2025 | |
| Europe is the largest biosimilar market, worth $18 billion at list prices and 55% larger than the US market, and far larger than China's. | 18 USD billion (list prices) | 2025 | |
| The European Medicines Agency authorized a record 44 biosimilars in 2025, against 26 approved by the US Food and Drug Administration. | 44 biosimilars | 2025 | |
| Denosumab was the busiest biosimilar molecule of 2025: the EU approved 12 biosimilars each for Prolia and Xgeva, and the US approved eight. | 12 biosimilars per reference product (EU) | 2025 | |
| 71% of biosimilars were approved in Europe before they were approved in the United States. | 71 % | 2025 | |
| Amgen's worldwide Prolia (denosumab) sales fell 45% year on year to $632 million in the third quarter of 2026 as several biosimilars launched around the world. | 632 USD million | 2026 | |
| Teva expects more than $0.8 billion of biosimilar revenue in 2026, a year ahead of its original target, and has widened its partnership with Samsung Bioepis. | 0.8 USD billion | 2026 |
Calculated figures (shares, changes and prices per kilogram) are plain arithmetic on the reported values. Read how we work.
Companies to watch
Amgen
Originator of Prolia and Xgeva, whose sales fell as denosumab biosimilars launched around the world in 2025 and 2026.
Teva Pharmaceutical Industries
Expects more than $0.8 billion of biosimilar revenue in 2026.
Samsung Bioepis
Biosimilar developer that expanded its commercial partnership with Teva in 2026.
What the full report covers
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the global market - 03Global market size, 2021 to 2025
Historical series and growth rates - 04Countries and regions
Demand, supply and trade by country and region - 05Outlook to 2031
Base, low and high scenarios with stated assumptions - 06Rules, policy and deadlines
Regulation and programmes that change demand - 07Drivers and barriers
What accelerates or slows adoption, by customer segment - 08Prices, costs and margins
Unit economics where public data allows - 09Competitive landscape
8 to 12 company profiles with recent moves - 10Opportunities and risks
For new entrants, suppliers and investors - 11Method and assumptions
How every figure was built
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Frequently asked questions
How big is the global biosimilars market?
There is no single world total in public primary data. Europe, the largest market, is worth $18 billion at list prices, 55% more than the US. Biologics with $143 billion of global sales still have no biosimilar in development.
Which region has the most biosimilars?
Europe. The EU authorized a record 44 biosimilars in 2025, against 26 in the US, and 71% of biosimilars were approved in Europe first.
Which biosimilars were approved most in 2025?
Denosumab. The EU approved 12 biosimilars each for Prolia and Xgeva in 2025, and the US approved eight.
How fast do biosimilars take sales from the originator?
Quickly. Amgen's Prolia sales fell 45% year on year to $632 million in the third quarter of 2026 as several denosumab biosimilars launched around the world.
Who are the main biosimilar companies?
Teva expects more than $0.8 billion of biosimilar revenue in 2026 and has expanded its partnership with Samsung Bioepis. Amgen faces biosimilar competition on Prolia and Xgeva.
What is the opportunity for new biosimilars?
Biologics with $143 billion of global sales in the year before they lose exclusivity in Europe, 55% of the total, have no biosimilar in development.
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