Where biosimilars are approved, and where they are not
The number of biosimilar products approved or registered in each market, for every molecule, and the molecules where a market still has none.
Reading the matrix
Each row is a molecule and each column a regulator. The number is how many biosimilar products are approved or registered in that market. A dot means none yet. The counts come from the same records as the molecule and product pages.
What the gaps show
A molecule with biosimilars in Europe but none in India, or in India but none in the Gulf, is a market where the first entrant has not yet arrived. The lists below the matrix group the molecules by these gaps. Because Gulf registration follows approval in Europe or the United States, the UAE gaps are usually the next to close.
Seven markets
United States
89 products across 21 molecules. Full list
European Union
110 products across 26 molecules. Full list
United Kingdom
110 products across 26 molecules. Full list
United Arab Emirates
35 products across 17 molecules. Full list
Molecule by market
| Molecule | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Adalimumab | 10 | 8 | 8 | 4 | 8 | 5 | 4 |
| Denosumab 3 under review (EU) | 10 | 12 | 11 | 1 | 4 | 5 | 2 |
| Bevacizumab 2 under review (EU) | 6 | 7 | 8 | 4 | 6 | 8 | 3 |
| Trastuzumab | 6 | 8 | 6 | 3 | 5 | 7 | 4 |
| Pegfilgrastim 2 under review (EU) | 8 | 8 | 6 | 1 | 5 | 6 | 4 |
| Ustekinumab | 8 | 8 | 8 | 4 | 6 | 1 | 2 |
| Aflibercept | 6 | 9 | 8 | 4 | 5 | 2 | · |
| Rituximab | 4 | 4 | 4 | 2 | 3 | 7 | 3 |
| Ranibizumab | 4 | 6 | 6 | 1 | 2 | 6 | 1 |
| Filgrastim 1 under review (EU) | 5 | 5 | 4 | 3 | 3 | 3 | 2 |
| Insulin glargine | 3 | 3 | 2 | 2 | 2 | 10 | 1 |
| Infliximab | 4 | 3 | 3 | 3 | 4 | 3 | 2 |
| Teriparatide | · | 5 | 9 | 1 | 1 | 4 | · |
| Etanercept | 2 | 3 | 3 | 2 | 3 | 4 | 1 |
| Tocilizumab | 3 | 4 | 4 | 2 | 2 | 1 | · |
| Insulin aspart 2 under review (EU) | 3 | 3 | 2 | 1 | 2 | 2 | 1 |
| Epoetin alfa and zeta | 1 | 2 | 2 | 1 | · | 7 | 1 |
| Enoxaparin sodium | · | 1 | 5 | · | 5 | · | 2 |
| Somatropin | · | 1 | 1 | 1 | 1 | 5 | 1 |
| Insulin human | · | · | · | · | 1 | 9 | · |
| Follitropin alfa | · | 2 | 2 | · | · | 3 | 1 |
| Insulin lispro | · | 2 | 1 | 1 | 1 | 2 | · |
| Omalizumab 2 under review (EU) | 1 | 1 | 2 | 1 | 1 | 1 | · |
| Pertuzumab 2 under review (EU) | 1 | 1 | 1 | · | · | 3 | · |
| Eculizumab | 2 | 2 | 2 | · | · | · | · |
| Darbepoetin alfa | · | · | · | 3 | · | 3 | · |
| Golimumab | 1 | 1 | 1 | 1 | · | 1 | · |
| Natalizumab | 1 | 1 | 1 | · | · | · | · |
| Interferon alfa-2b | · | · | · | · | · | 3 | · |
| Agalsidase beta | · | · | · | 1 | · | · | · |
| Vedolizumab 2 under review (EU) | · | · | · | · | · | · | · |
| Abatacept 1 under review (EU) | · | · | · | · | · | · | · |
Counts are development products approved or registered; brands of the same product count once. A dot means no product in that market as of Sep 2026.
The gaps
Approved in the United States or the European Union, no permission in India (3)
Permitted in India, no biosimilar in the United States (7)
Permitted in India, no biosimilar in the European Union (3)
Approved in the United States or the European Union, none registered in the UAE (9)
Approved in Japan, none in the United States (5)
Approved in the United States or the European Union, none in Japan (5)
Approved in the United States or the European Union, none in Canada (6)
Approved in the European Union, not licensed in the United Kingdom (0)
None.
Biosimilars in every one of the seven markets (13)
No approved biosimilar in any of the seven markets (2)
A molecule with biosimilars in Europe and none in India, or in India and none in the Gulf, is a market-entry question. EvySaif prepares the regulatory pathway and dossier strategy for exactly that decision. Regulatory strategy consulting
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