Celltrion Receives Positive CHMP Opinion for Eylea Biosimilar in the European Union

Celltrion announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions and recommended marketing authorizations for three biosimilar candidates, including Eydenzelt (CT-P42, aflibercept).

Eydenzelt (40 mg/mL solution for injection in vial and pre-filled syringe), a biosimilar to Eylea, is recommended for approval to treat multiple retinal disorders, including wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME), and myopic choroidal neovascularisation (myopic CNV). In a phase 3 study of Eydenzelt, the efficacy, safety, pharmacokinetics and immunogenicity of Eydenzelt was compared to Eylea in patients with diabetic macular edema (DME), demonstrating therapeutic equivalence to Eylea by meeting the predefined equivalence criteria.[1]

If marketing authorization is granted by the European Commission (EC), Eydenzelt would be one of the first-wave aflibercept biosimilars in Europe.

Celltrion also received positive CHMP opinions for Stoboclo and Osenvelt (CT-P41, denosumab), and Avtozma (CT-P47, tocilizumab).

The CHMP’s recommendations will now be referred to the EC, which will decide whether to grant a marketing authorization.

References

1. Sebastian Wolf et al., Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42 3.1. [EURETINA 2024, Abstract #CA24-2257-8397]. Available at: https://abstracts.euretina.org/2024/ca24-2257-8397/r/recxUD7DqYfFfjC7s [Last accessed December 2024].