Biosimilar Atlas
Biosimilar approvals in the United States, the European Union, India and the UAE, molecule by molecule, from the records of FDA, EMA, CDSCO and EDE.
Adalimumab
Trastuzumab
Denosumab
Bevacizumab
Insulin glargine
Ustekinumab
Rituximab
Infliximab
Etanercept
Ranibizumab
Pegfilgrastim
Filgrastim
Aflibercept
Tocilizumab
Next molecules
insulin aspart, insulin lispro, golimumab, omalizumab, pertuzumab, teriparatide, eculizumab, natalizumab, somatropin, follitropin alfa.
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.
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