EMA CHMP 对 Fovlussea（ranibizumab 生物类似药）给出正面意见
Human medicines European public assessment report (EPAR): Fovlussea, ranibizumab, Ophthalmologicals, Status: Opinion
CHMP 于 2026 年 10 月 15 日对 Accord Healthcare S.L.U. 的 Fovlussea（ranibizumab）给出正面意见，建议批准其上市。该药为 Lucentis 的生物类似药，剂型为 10 mg/ml 注射液，拟用于湿性年龄相关性黄斑变性、糖尿病黄斑水肿、增殖性糖尿病视网膜病变、视网膜静脉阻塞继发黄斑水肿及脉络膜新生血管所致视力损害。
Overview
On 15 October 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Fovlussea, 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 Accord Healthcare S.L.U.
Fovlussea will be available as 10 mg/ml solution for injection. The active substance of Fovlussea is ranibizumab, an antineovascularisation agent (ATC code: S01LA04). Ranibizumab is a monoclonal antibody fragment which modulates angiogenesis by inhibiting vascular endothelial growth factor A.
Fovlussea 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 Fovlussea has comparable quality, safety and efficacy to Lucentis.
The full indication is:
Fovlussea 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).
Fovlussea 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 on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Product details
Name of medicine
Fovlussea
Active substance
ranibizumab
International non-proprietary name (INN) or common name
ranibizumab
Therapeutic area (MeSH)
- Wet Macular Degeneration
- Macular Edema
- Diabetes Complications
- Choroidal Neovascularization
Anatomical therapeutic chemical (ATC) code
S01LA04
EMA product number
EMEA/H/C/006940
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
Accord Healthcare S.L.U.
Opinion adopted
15/10/2026
Opinion status
Positive
来源：EMA New Medicine · ema.europa.eu