Cimerli / Ranivisio
Ranibizumab biosimilar developed by Bioeq (Formycon and Polpharma), development code FYB201. Reference product Lucentis.
About Cimerli / Ranivisio
This ranibizumab was developed by Bioeq, a joint venture of Formycon and Polpharma. In the United States it is Cimerli, sold by Sandoz, approved in 2022 and interchangeable from the start. In Europe it is Ranivisio, and later also Epruvy, both held by Midas Pharma. It was the second ranibizumab biosimilar in each market.
Status by market
United States · Cimerli
US Food and Drug AdministrationApprovedEuropean Union · Ranivisio
European Medicines Agency and European CommissionApprovedEuropean Union · Epruvy
European Medicines Agency and European CommissionApprovedUnited Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Cimerli / Ranivisio by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| FYB201 | Bioeq | Lucentis | Phase 3 | Comparative efficacy | Completed | Dec 2015 | Dec 2017 | NCT02611778 |
Other developers in the same markets
Where Cimerli / Ranivisio holds an approval, these are the other ranibizumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 3 | Lupin (Ranluspec / Vislyfa), Samsung Bioepis (Byooviz), Zydus Lifesciences (Nufymco) |
| EMA | 5 | Intas Pharmaceuticals (Rexatilux / Razumab), Lupin (Ranluspec / Vislyfa), Qilu Pharmaceutical (Rimmyrah), Samsung Bioepis (Byooviz), Xbrane Biopharma (Ximluci) |
Chronology
- FDAAug 2022Approved by FDA as Cimerli
- EMAAug 2022Authorised by the European Commission as Ranivisio
- EMASep 2024Authorised by the European Commission as Epruvy
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
Planning ranibizumab biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultant