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 · Company profile
FDAJun 2026approved
EMAFeb 2026authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCOOct 2021permitted
EDENot listed
Approved or registered in 4 of 7 markets
Connections
About Ranluspec / Vislyfa
Lupin's ranibizumab was permitted in India in 2021 and reached Europe in February 2026 as Ranluspec, with a second European name, Vislyfa, in July. The United States approved Ranluspec in June 2026 as interchangeable. It is the second Indian ranibizumab to reach the United States, after Zydus's.
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
Reference product in the Purple Book
Lucentis
Marketing status (Purple Book)
Prescription, marketed
Presentations
10 mg/mL and 6 mg/mL
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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) · checked Sep 2026
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
Remarks
Second Lupin brand.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Ranluspec
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Ranluspec
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
10 mg/mL vial and syringe
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
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 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Ranluspec / Vislyfa 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 |
|---|---|---|---|---|---|---|---|---|
| LUBT010 | Lupin | Lucentis | Phase 3 | Comparative efficacy | Completed | Sep 2020 | May 2024 | NCT04690556 |
Other developers in the same markets
Where Ranluspec / Vislyfa holds an approval, these are the other ranibizumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 3 | Bioeq (Cimerli / Ranivisio), Samsung Bioepis (Byooviz), Zydus Lifesciences (Nufymco) |
| EMA | 5 | Bioeq (Cimerli / Ranivisio), Intas Pharmaceuticals (Rexatilux / Razumab), Qilu Pharmaceutical (Rimmyrah), Samsung Bioepis (Byooviz), Xbrane Biopharma (Ximluci) |
| MHRA | 4 | Not stated in the MHRA list (Ongavia), Qilu Pharmaceutical (Rimmyrah), Samsung Bioepis (Byooviz), Xbrane Biopharma (Ximluci) |
| CDSCO | 5 | Enzene Biosciences (Enzene Biosciences ranibizumab), Intas Pharmaceuticals (Rexatilux / Razumab), Reliance Life Sciences (Reliance Life Sciences ranibizumab), Sun Pharmaceutical Industries (Sun Pharma ranibizumab), Zenotech Laboratories (Zenotech ranibizumab) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Lupin: Armlupeg / Lupin pegfilgrastim, Lupin denosumab, Lupin filgrastim, Lupin insulin glargine, Nepexto / Fubelv / Lupin etanercept.
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)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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