Home/Biosimilar Atlas/Ranibizumab/Rexatilux / Razumab

Rexatilux / Razumab

Ranibizumab biosimilar developed by Intas Pharmaceuticals. Reference product Lucentis.

Brands by market: Rexatilux (EU); Razumab (India) · Commercial partner or holder: Intas Pharmaceuticals (Accord in the EU) · Company profile
FDANot listed
EMAJun 2026authorised
MHRANot listed
PMDANot listed
HCNot listed
CDSCOFeb 2015permitted
EDENot listed
Approved or registered in 2 of 7 markets
Connections
RanibizumabmoleculeIntas Pharmaceuticalsdeveloper2 of 7markets0trials behind it11other products, same developer9rival developers in its markets

About Rexatilux / Razumab

Razumab is Intas's ranibizumab, the first ranibizumab biosimilar approved anywhere in the world, in India in February 2015, six years before Europe or the United States. Retinopathy of prematurity was added in 2022. In June 2026 the same product was approved in Europe as Rexatilux, through Intas's own European company.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Rexatilux

European Medicines Agency and European CommissionApproved
Brand
Rexatilux
Holder or applicant
Intas Third Party Sales 2005 S.L.
Pathway
Centralised (Article 10(4))
Approved
Jun 2026
Application or permission
EMEA/H/C/006634
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India · Razumab

Central Drugs Standard Control OrganisationApproved
Brand
Razumab
Holder or applicant
Intas Pharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Feb 2015
Application or permission
MF-35/2015; BULK-36/2015; additional indication July 2022 (retinopathy of prematurity)
Indications as licensed
Wet AMD, DME, RVO, CNV; retinopathy of prematurity added July 2022
Presentations
2.3 mg/0.23 mL single-use vial (10 mg/mL)
Remarks
First ranibizumab biosimilar approved anywhere.
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Rexatilux / Razumab holds an approval, these are the other ranibizumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
EMA5Bioeq (Cimerli / Ranivisio), Lupin (Ranluspec / Vislyfa), Qilu Pharmaceutical (Rimmyrah), Samsung Bioepis (Byooviz), Xbrane Biopharma (Ximluci)
CDSCO5Enzene Biosciences (Enzene Biosciences ranibizumab), Lupin (Ranluspec / Vislyfa), 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 Intas Pharmaceuticals: Accofil / Filkri, Intas bevacizumab, Intas etanercept, Intas follitropin alfa, Intas peginterferon alfa-2b, Intas pertuzumab, Intas rituximab, Intas trastuzumab, Osvyrti / Jubereq, Pelgraz / Ennumo, Sondelbay / Intas teriparatide.

Chronology

Sources

All ranibizumab biosimilars

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Data current to September 2026.