Ranluspec / Vislyfa
Ranibizumab biosimilar developed by Lupin. Reference product Lucentis.
Brands by market: Ranluspec (USA, EU); Vislyfa (EU); brand not published by CDSCO (India) · Commercial partner or holder: Lupin
FDAJun 2026approved
EMAFeb 2026authorised
CDSCOOct 2021permitted
EDEnot listed
Status by market
FDA
United States · Ranluspec
US Food and Drug AdministrationApprovedBrand
Ranluspec
Holder or applicant
Lupin Limited (Biotech Division)
Pathway
351(k)
Approved
Jun 2026
Application or permission
761480
Licence type
351(k) interchangeable, designated Jun 2026
Presentations
10 mg/mL and 6 mg/mL
Source
S001, S016
EMA
European Union · Ranluspec
European Medicines Agency and European CommissionApprovedBrand
Ranluspec
Holder or applicant
Lupin Europe GmbH
Pathway
Centralised (Article 10(4))
Approved
Feb 2026
Application or permission
EMEA/H/C/006502
Presentations
see SmPC
Source
S017
EMA
European Union · Vislyfa
European Medicines Agency and European CommissionApprovedBrand
Vislyfa
Holder or applicant
Lupin Europe GmbH
Pathway
Centralised (Article 10(4))
Approved
Jul 2026
Application or permission
EMEA/H/C/006926
Presentations
see SmPC
Note
Second Lupin brand.
Source
S017
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Lupin Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Oct 2021
Application or permission
MF/BIO/21/000119; drug substance MF/BULK/BD/314/2021; additional indications June 2022 and MF/BIO/26/000016
Indications as licensed
Wet AMD at permission; DME, RVO and CNV added June 2022; PDR and retinopathy of prematurity added February 2026
Presentations
10 mg/mL vial
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOOct 2021CDSCO permission granted
- EMAFeb 2026Authorised by the European Commission as Ranluspec
- FDAJun 2026Approved by FDA as Ranluspec
- EMAJul 2026Authorised by the European Commission as Vislyfa
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)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) 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 consultantData current to September 2026.