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Biosimilar Atlas

Explore the global biosimilar landscape through regulatory approvals, molecules and markets.

32molecules
296development products
697regulatory records
7regulators: FDA, EMA, MHRA, PMDA, Health Canada, CDSCO, EDE
Therapeutic area
FDA, United StatesEMA, European UnionMHRA, United KingdomPMDA, JapanHealth CanadaCDSCO, IndiaEDE, UAE

Adalimumab

Humira, AbbVie
Immunology · Monoclonal antibody
10FDA8 interch.
8EMA4 withdr.
8MHRA
4PMDA
8HC
5CDSCO
4EDE
18 development products, 54 regulatory records

Trastuzumab

Herceptin, Roche
Oncology · Monoclonal antibody
6FDA
8EMA2 withdr.
6MHRA
3PMDA
5HC
7CDSCO
4EDE
14 development products, 42 regulatory records

Denosumab

Prolia and Xgeva, Amgen
Endocrinology · Monoclonal antibody
10FDA10 interch.
12EMA3 review
11MHRA
1PMDA
4HC
5CDSCO
2EDE
20 development products, 93 regulatory records

Bevacizumab

Avastin, Roche
Oncology · Monoclonal antibody
6FDA
7EMA3 withdr.
2 review
8MHRA
4PMDA
6HC
8CDSCO
3EDE
23 development products, 49 regulatory records

Insulin glargine

Lantus, Sanofi
Diabetes · Insulin analogue
3FDA3 interch.
3EMA1 withdr.
2MHRA
2PMDA
2HC
10CDSCO
1EDE
13 development products, 24 regulatory records

Ustekinumab

Stelara, Johnson & Johnson
Immunology · Monoclonal antibody
8FDA8 interch.
8EMA3 withdr.
8MHRA
4PMDA
6HC
1CDSCO
2EDE
13 development products, 43 regulatory records

Rituximab

MabThera (Rituxan in the United States), Roche
Oncology · Monoclonal antibody
4FDA1 interch.
4EMA2 withdr.
4MHRA
2PMDA
3HC
7CDSCO
3EDE
12 development products, 32 regulatory records

Infliximab

Remicade, Johnson & Johnson
Immunology · Monoclonal antibody
4FDA
3EMA1 withdr.
3MHRA
3PMDA
4HC
3CDSCO
2EDE
7 development products, 26 regulatory records

Etanercept

Enbrel, Amgen
Immunology · Fusion protein
2FDA1 interch.
3EMA
3MHRA
2PMDA
3HC
4CDSCO
1EDE
7 development products, 20 regulatory records

Ranibizumab

Lucentis, Genentech
Ophthalmology · Monoclonal antibody fragment
4FDA4 interch.
6EMA
6MHRA
1PMDA
2HC
6CDSCO
1EDE
15 development products, 28 regulatory records

Pegfilgrastim

Neulasta, Amgen
Hematology · Pegylated growth factor
8FDA
8EMA1 withdr.
2 review
6MHRA
1PMDA
5HC
6CDSCO
4EDE
19 development products, 44 regulatory records

Filgrastim

Neupogen, Amgen
Hematology · Growth factor
5FDA
5EMA3 withdr.
1 review
4MHRA
3PMDA
3HC
3CDSCO
2EDE
13 development products, 31 regulatory records

Aflibercept

Eylea, Regeneron
Ophthalmology · Fusion protein
6FDA2 interch.
9EMA1 withdr.
8MHRA
4PMDA
5HC
2CDSCO
0EDE
13 development products, 38 regulatory records

Tocilizumab

Actemra (RoActemra in the European Union), Roche
Immunology · Monoclonal antibody
3FDA1 interch.
4EMA
4MHRA
2PMDA
2HC
1CDSCO
0EDE
6 development products, 16 regulatory records

Insulin aspart

NovoRapid (NovoLog in the United States), Novo Nordisk
Diabetes · Insulin analogue
3FDA1 interch.
3EMA1 withdr.
2 review
2MHRA
1PMDA
2HC
2CDSCO
1EDE
7 development products, 17 regulatory records

Insulin lispro

Humalog, Eli Lilly
Diabetes · Insulin analogue
0FDA
2EMA
1MHRA
1PMDA
1HC
2CDSCO
0EDE
4 development products, 7 regulatory records

Omalizumab

Xolair, Genentech
Immunology · Monoclonal antibody
1FDA1 interch.
1EMA2 review
2MHRA
1PMDA
1HC
1CDSCO
0EDE
5 development products, 9 regulatory records

Pertuzumab

Perjeta, Roche
Oncology · Monoclonal antibody
1FDA1 interch.
1EMA2 review
1MHRA
0PMDA
0HC
3CDSCO
0EDE
6 development products, 8 regulatory records

Golimumab

Simponi (Simponi Aria intravenous in the United States), Johnson & Johnson
Immunology · Monoclonal antibody
1FDA1 interch.
1EMA
1MHRA
1PMDA
0HC
1CDSCO
0EDE
4 development products, 7 regulatory records

Eculizumab

Soliris, Alexion
Rare disease · Monoclonal antibody
2FDA2 interch.
2EMA
2MHRA
0PMDA
0HC
0CDSCO
0EDE
2 development products, 7 regulatory records

Natalizumab

Tysabri, Biogen
Neurology · Monoclonal antibody
1FDA
1EMA
1MHRA
0PMDA
0HC
0CDSCO
0EDE
1 development products, 3 regulatory records

Teriparatide

Forsteo (Forteo in the United States), Eli Lilly
Endocrinology · Peptide hormone
0FDA
5EMA1 withdr.
9MHRA
1PMDA
1HC
4CDSCO
0EDE
16 development products, 23 regulatory records

Epoetin alfa and zeta

Eprex (Epogen and Procrit in the United States), Amgen
Hematology · Glycoprotein hormone
1FDA
2EMA
2MHRA
1PMDA
0HC
7CDSCO
1EDE
10 development products, 17 regulatory records

Somatropin

Genotropin (Omnitrope's reference); also Norditropin, Humatrope, Saizen, Pfizer
Endocrinology · Peptide hormone
0FDA
1EMA1 withdr.
1MHRA
1PMDA
1HC
5CDSCO
1EDE
7 development products, 11 regulatory records

Follitropin alfa

Gonal-f, Merck
Fertility · Glycoprotein hormone
0FDA
2EMA
2MHRA
0PMDA
0HC
3CDSCO
1EDE
5 development products, 8 regulatory records

Enoxaparin sodium

Clexane (Lovenox in the United States), Sanofi
Hematology · Low-molecular-weight heparin
0FDA
1EMA1 withdr.
5MHRA
0PMDA
5HC
0CDSCO
2EDE
10 development products, 14 regulatory records

Vedolizumab

Entyvio, Takeda
Immunology · Monoclonal antibody
0FDA
0EMA2 review
0MHRA
0PMDA
0HC
0CDSCO
0EDE
2 development products, 2 regulatory records

Abatacept

Orencia, Bristol Myers Squibb
Immunology · Fusion protein
0FDA
0EMA1 review
0MHRA
0PMDA
0HC
0CDSCO
0EDE
1 development products, 1 regulatory records

Darbepoetin alfa

Aranesp (Nesp in Japan), Amgen
Hematology · Glycoprotein hormone
0FDA
0EMA
0MHRA
3PMDA
0HC
3CDSCO
0EDE
6 development products, 6 regulatory records

Agalsidase beta

Fabrazyme, Sanofi
Rare disease · Enzyme
0FDA
0EMA
0MHRA
1PMDA
0HC
0CDSCO
0EDE
1 development products, 1 regulatory records

Insulin human

Humulin (Lilly); Actrapid, Insulatard and Mixtard (Novo Nordisk); Insuman (Sanofi), Eli Lilly; Novo Nordisk; Sanofi
Diabetes · Hormone
0FDA
0EMA2 withdr.
0MHRA
0PMDA
1HC
9CDSCO
0EDE
12 development products, 12 regulatory records

Interferon alfa-2b

Intron A and PegIntron (Merck), Merck
Infectious disease · Cytokine
0FDA
0EMA1 withdr.
0MHRA
0PMDA
0HC
3CDSCO
0EDE
4 development products, 4 regulatory records

Next molecules

interferon beta-1a, liraglutide, secukinumab, dupilumab, nivolumab, pembrolizumab, daratumumab, ocrelizumab, ipilimumab, romiplostim.

Why we built the Atlas

Biologic medicines have transformed the treatment of cancer, arthritis, diabetes, kidney disease and eye disease. They have also become some of the most expensive medicines in healthcare. For a long time, access to these treatments depended heavily on where a patient lived and what their healthcare system could afford. Biosimilars have started to change that by giving healthcare systems more affordable alternatives to established biologic medicines. India was an early leader in biosimilars, and their use is now expanding across major markets around the world.

The economics are an important part of this. A biosimilar does not have to go through the same discovery and development process as the original biologic, which can reduce the cost of bringing it to market. When several products compete in the same market, this can create room for lower prices and wider access. For a hospital, that can mean treating more patients within the same budget. For a healthcare system, it can make more treatment options financially possible. For patients, it can make an important difference to whether a treatment is affordable at all.

But understanding the biosimilar landscape is difficult. Biologics are complex medicines produced using living cells, and demonstrating biosimilarity requires extensive analytical, non-clinical and clinical evidence. At the same time, each regulatory market has its own approval process, terminology and databases. The information exists, but it is spread across regulatory websites, approval documents and company sources. Even a simple question such as "Is there a biosimilar for this molecule, and where is it approved?" can take considerable time to answer properly.

This is why we built the Atlas. We wanted a single place where the global biosimilar landscape could be explored without having to search through multiple regulatory databases every time. The Atlas brings together biosimilars approved in the United States, Europe, the United Kingdom, Japan, Canada, India and the UAE, with information on the molecule, product, manufacturer, marketing company and approval date. You can explore the landscape by molecule, company or market, and each entry points back to its regulatory source so the information can be verified and used for further work.

We built it with practical use in mind. A company evaluating a new biosimilar opportunity can use it to understand existing competition across markets. A buyer or hospital pharmacist can check which products are approved in a particular country. Researchers, students and others working in the field can use it to study how biosimilar approvals have evolved. The Atlas is free to use, and we will continue adding products, companies and markets as the landscape develops.

EvySaif works with companies on biosimilar development, regulatory strategy, submissions and scientific and medical writing. We originally started building the Atlas because we needed a reliable way to find and compare this information in our own work. As the database grew, we realised that the same information could be useful to many others working in biosimilars. So we decided to make it public rather than keep it as an internal resource.

By market

United States

89 products approved across 21 molecules. Full list

European Union

110 products approved across 26 molecules. Full list

United Kingdom

110 products approved across 26 molecules. Full list

Japan

47 products approved across 23 molecules. Full list

Canada

70 products approved across 21 molecules. Full list

India

111 products approved across 26 molecules. Full list

United Arab Emirates

35 products registered across 17 molecules. Full list

See also: where each molecule has a biosimilar and where it does not, and the full list of FDA-designated interchangeable biosimilars.

Looking for a developer rather than a molecule? Browse the 90 companies in the Atlas, each with its portfolio and approvals by market.

United States

Approval month, BLA number, licence type and interchangeability from FDA's Purple Book and approved-biosimilar table.

European Union

Product number, marketing authorisation holder, authorisation month and withdrawals from EMA's medicines data and each product's EPAR.

United Kingdom

Products licensed for each molecule from the MHRA substance lists, with presentations. The list does not show holder, licence number or date.

Japan

Brand, marketing authorisation holder, approval date and indications from PMDA's list of approved biosimilar products.

Canada

Brand, DIN owner, first approval or market date and strengths from Health Canada's Drug Product Database extract, using its biosimilar flag.

India and UAE

Firm, permission number and month from CDSCO's published lists of approved r-DNA products; UAE registrations from the Emirates Drug Establishment directory.

Work with EvySaif

Biosimilar landscape report

The register for any molecule as a delivered document: every approval, holder, presentation and pathway requirement across FDA, EMA, CDSCO and the Gulf, with the sources attached. Available for molecules not yet published here.

Request a landscape report

Regulatory gap assessment

For a developer deciding whether and where to file: a review of your analytical, PK and clinical package against what each regulator expects, with the gaps ranked and a filing sequence recommended.

About the gap assessment

Need a molecule that is not published yet?

Tell us the molecule and the markets. EvySaif prepares biosimilar landscape reports and regulatory strategy for developers in India, the European Union and the Gulf.

Request a biosimilar landscape
Data current to September 2026.