Overview

On 25 July 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ranibizumab Midas, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularisation.

The applicant for this medicinal product is Midas Pharma GmbH.

Ranibizumab Midas will be available as a 10 mg/ml solution for injection. The active substance of Ranibizumab Midas is ranibizumab, a monoclonal antibody fragment (ATC code: S01LA04) which modulates angiogenesis by inhibiting vascular endothelial growth factor A.

Ranibizumab Midas is a biosimilar medicinal product. It is highly similar to the reference product Lucentis (ranibizumab), which was authorised in the EU on 22/01/2007. Data show that Ranibizumab Midas has comparable quality, safety and efficacy to Lucentis (ranibizumab). More information on biosimilar medicines can be found in the Biosimilars in the EU information guide.

Ranibizumab Midas is a duplicate of Ranivisio, which was authorised in the EU on 25 August 2022. Duplicate medicines have identical composition and pharmaceutical form.

The full indication is:

Ranibizumab Midas 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).

Ranibizumab Midas must be administered by a qualified ophthalmologist experienced in intravitreal injections.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Ranibizumab Midas

AdoptedReference Number: EMA/CHMP/332433/2024

English (EN) (158.54 KB - PDF)

First published:
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Product details

Name of medicine
Ranibizumab Midas
Active substance
ranibizumab
International non-proprietary name (INN) or common name
ranibizumab
Therapeutic area (MeSH)
  • Wet Macular Degeneration
  • Macular Edema
  • Choroidal Neovascularization
  • Diabetes Complications
Anatomical therapeutic chemical (ATC) code
S01LA04
EMA product number
EMEA/H/C/006528

Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Marketing authorisation applicant
Midas Pharma GmbH
Opinion adopted
25/07/2024
Opinion status
Positive
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