Opuviz

Opinion

EMA has issued an opinion on this medicine

aflibercept

Overview

On 19 September 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 Opuviz, intended for the treatment of neovascular (wet) age-related macular degeneration,visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

The applicant for this medicinal product is Samsung Bioepis NL B.V.

Opuviz will be available as 40 mg/ml solution for injection. The active substance of Opuviz is aflibercept, an antineovascularisation agent (ATC code: S01LA05). Aflibercept is a recombinant fusion protein consisting of the extracellular domains of human VEGF receptor 1 and 2 fused to the Fc portion of human IgG1. By acting as a soluble decoy for the natural VEGF receptors, aflibercept inhibits their activation, thereby reducing angiogenesis.

Opuviz is a biosimilar medicinal product. It is highly similar to the reference product Eylea (aflibercept), which was authorised in the EU on 22 November 2012. Data show that Opuviz has comparable quality, safety and efficacy to Eylea. 

The full indication is:

Opuviz is indicated for adults for the treatment of

• neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),
• visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),
• visual impairment due to diabetic macular oedema (DME) (see section 5.1),
• visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

Opuviz must be administered by a qualified physician experienced in administering 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 Opuviz

AdoptedReference Number: EMA/364707/2024

Product details

• Name of medicine:
  Opuviz
• Active substance:
  aflibercept
• International non-proprietary name (INN) or common name:
  aflibercept
• Therapeutic area (MeSH):
  • Wet Macular Degeneration
  • Macular Edema
  • Diabetes Complications
  • Retinal Vein Occlusion
• Anatomical therapeutic chemical (ATC) code:
  S01LA05
• EMA product number:
  EMEA/H/C/006056
• 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:
  Samsung Bioepis NL B.V.
• Opinion adopted:
  19/09/2024
• Opinion status:
  Positive