Cimerli / Ranivisio
Ranibizumab biosimilar developed by Bioeq (Formycon and Polpharma), development code FYB201. Reference product Lucentis.
Brands by market: Cimerli (USA); Ranivisio and Epruvy (EU) · Commercial partner or holder: Sandoz (USA); Midas Pharma (EU)
FDAAug 2022approved
EMAAug 2022authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Cimerli
US Food and Drug AdministrationApprovedBrand
Cimerli
Holder or applicant
Sandoz Inc.
Pathway
351(k)
Approved
Aug 2022
Application or permission
761165
Licence type
351(k) interchangeable, designated Aug 2022
Presentations
10 mg/mL and 6 mg/mL vials
Note
Interchangeable on licensure.
Source
S001, S016
EMA
European Union · Ranivisio
European Medicines Agency and European CommissionApprovedBrand
Ranivisio
Holder or applicant
Midas Pharma GmbH
Pathway
Centralised (Article 10(4))
Approved
Aug 2022
Application or permission
EMEA/H/C/005019
Indications as licensed
Wet AMD, DME, PDR, RVO, CNV
Presentations
see SmPC
Source
S017
EMA
European Union · Epruvy
European Medicines Agency and European CommissionApprovedBrand
Epruvy
Holder or applicant
Midas Pharma GmbH
Pathway
Centralised (Article 10(4))
Approved
Sep 2024
Application or permission
EMEA/H/C/006528
Presentations
see SmPC
Note
Second Midas brand, previously Ranibizumab Midas.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
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)
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