New batch of EC nods for Celltrion biosimilars

20 February 2025

South Korea-based Celltrion (Kosdaq: 068270) today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars.

The first product is Eydenzelt (CT-P42, aflibercept), a biosimilar to Bayer’s (BAYN: DE) Eylea to treat multiple retinal disorders, including neovascular (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).

Also approved area Celltrion’s Stoboclo and Osenvelt (CT-P41, denosumab), biosimilars referencing Amgen’s (Nasdaq: AMGN) Prolia and Xgeva brands used for all indications of the reference products. The EC approval expands Celltrion’s diverse biosimilars portfolio across multiple therapeutic areas such as skeletal-related disorders and ophthalmology, the company noted.

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