CHMP recommends ranibizumab biosimilar Fovlussea for retinal disease

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Fovlussea (ranibizumab; Accord Healthcare), a biosimilar referencing Lucentis (ranibizumab; Novartis).¹ The positive opinion, adopted on 15 October 2026, covers neovascular age-related macular degeneration (nAMD), visual impairment due to diabetic macular oedema (DMO), proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularisation (CNV).²

Fovlussea enters a European market where ranibizumab biosimilars have been commercially available since 2023, including Byooviz (Samsung Bioepis) and Ximluci (STADA/Xbrane).³ The recommendation was 1 of 2 biosimilar opinions issued at the committee's October meeting, held 12 to 15 October 2026, alongside a filgrastim biosimilar.¹

Fovlussea biosimilarity and indications under the CHMP opinion

The CHMP concluded Fovlussea is highly similar to Lucentis, which received EU authorisation on 22 January 2007. Ranibizumab is a monoclonal antibody fragment which inhibits vascular endothelial growth factor A (VEGF-A), and Fovlussea will be supplied as a 10 mg/mL solution for injection. Per the summary of opinion, Fovlussea must be administered by a qualified ophthalmologist experienced in intravitreal injections.²

Under the EU biosimilar framework, a comparability exercise covering quality, nonclinical and clinical data can support extrapolation to the indications held by the reference product. The recommended indications match the adult Lucentis label across nAMD, DMO, proliferative diabetic retinopathy, RVO and CNV.²

According to the EMA, data show Fovlussea has comparable quality, safety and efficacy to Lucentis.² Neither the meeting highlights nor the summary of opinion identifies the pivotal trial or reports its results. The EMA will publish the full European public assessment report (EPAR), including the comparative clinical data behind the opinion, after the European Commission issues its decision.⁴

What happens after the CHMP opinion on Fovlussea?

The summary of opinion does not report ocular safety outcomes, such as rates of intraocular inflammation, endophthalmitis or intraocular pressure elevation. These data are expected in the EPAR or from Accord directly.

The European Commission typically issues a decision within 67 days of a CHMP opinion. A positive decision would authorise Fovlussea across all EU member states as well as Iceland, Liechtenstein and Norway. Pricing, reimbursement and launch timing will then be set at the national level.

With the CHMP opinion, Accord becomes the latest company to seek a share of the European ranibizumab market, nearly 2 decades after the reference product's EU authorisation.^1,2 Uptake will depend on national tendering and reimbursement decisions across member states.

References
1. European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026. Published 16 October 2026. Accessed 20 October 2026. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-october-2026
2. European Medicines Agency. CHMP summary of positive opinion: Fovlussea. Accessed 20 October 2026. https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-fovlussea_en.pdf
3. EU Clinical Trials Register. A double masked, parallel group, randomized, multicenter, clinical study to compare efficacy and safety of Intas ranibizumab with Lucentis in patients with neovascular (wet) age-related macular degeneration (AMD). EudraCT 2021-001970-41. Accessed 20 October 2026. https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001970-41/LV
4. Pearce IP. Positive CHMP opinions for Accord's biosimilar ranibizumab and CuraTeQ's biosimilar filgrastim. Published 16 October 2026. Accessed 20 October 2026. https://www.pearceip.law/2026/10/16/positive-chmp-opinions-for-accords-biosimilar-ranibizumab-and-curateqs-biosimilar-filgrastim-expanded-indications-for-novo-nordisks-kyinsu-janssens-talvey/

Frequently asked questions:

What is Fovlussea recommended for?
The CHMP recommended Fovlussea for nAMD, DMO, proliferative diabetic retinopathy, macular oedema secondary to RVO and CNV in adults.

How does Fovlussea work?
Fovlussea is a ranibizumab biosimilar, a monoclonal antibody fragment which binds and inhibits VEGF-A.

When will Fovlussea be available in Europe?
The European Commission typically decides within 67 days of a CHMP opinion; launch timing then depends on national pricing and reimbursement.