Biosimilar Atlas
Explore the global biosimilar landscape through regulatory approvals, molecules and markets.
Adalimumab
Trastuzumab
Denosumab
Bevacizumab
2 review
Insulin glargine
Ustekinumab
Rituximab
Infliximab
Etanercept
Ranibizumab
Pegfilgrastim
2 review
Filgrastim
1 review
Aflibercept
Tocilizumab
Insulin aspart
2 review
Insulin lispro
Omalizumab
Pertuzumab
Golimumab
Eculizumab
Natalizumab
Teriparatide
Epoetin alfa and zeta
Somatropin
Follitropin alfa
Enoxaparin sodium
Vedolizumab
Abatacept
Darbepoetin alfa
Agalsidase beta
Insulin human
Interferon alfa-2b
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
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 reportRegulatory 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 assessmentNeed 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