Ranluspec (ranibizumab)
- Region
- 🇪🇺 EU
- Active substance
- ranibizumab
- Company
- Lupin Europe GmbH
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications; Retinal Vein Occlusion; Choroidal Neovascularization
- CHMP opinion
- Thu 11 Dec 2025
- EU approval
- Tue 10 Feb 2026
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006502
- ATC
- S01LA04
- Official record
- www.ema.europa.eu
Indication
Ranluspec is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)
Regulatory milestones
FDA approves biosimilar Ranluspec (ranibizumab-hkdz)
Lupin Limited; BLA761480; Biosimilar; injection · source
Ranluspec (ranibizumab) approved in the EU
Marketing authorisation to Lupin Europe GmbH; Biosimilar, Additional monitoring · source
Ranluspec (ranibizumab): CHMP positive opinion
Lupin Europe GmbH; Biosimilar, Additional monitoring · source
Same substance in other markets
- 🇪🇺 Fovlussea Opinion · Accord Healthcare S.L.U.
- 🇪🇺 Lucentis Authorised · Novartis Europharm Limited
- 🇪🇺 Byooviz Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Epruvy (previously Ranibizumab Midas) Authorised · Midas Pharma GmbH
- 🇪🇺 Ximluci Authorised · STADA Arzneimittel AG
- 🇪🇺 Susvimo Authorised · Roche Registration GmbH
- 🇪🇺 Vislyfa Authorised · Lupin Europe GmbH
- 🇪🇺 Ranivisio Authorised · Midas Pharma GmbH
- 🇪🇺 Rimmyrah Authorised · Qilu Pharma Spain S.L.
- 🇺🇸 Nufymco Approved · Formycon Ag
- 🇺🇸 Ranluspec Approved · Lupin Limited
- 🇪🇺 Rexatilux Authorised · Intas Third Party Sales 2005 S.L.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.