Celltrion's Biosimilars Receive CHMP Approval And Recommendations

Celltrion announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions recommending marketing authorisations for three of its biosimilar candidates: Eydenzelt® (CT-P42, aflibercept), Stoboclo® and Osenvelt® (CT-P41, denosumab), and Avtozma® (CT-P47, tocilizumab). This achievement highlights Celltrion’s leadership in biosimilar innovation and its dedication to improving access to biologic treatments across Europe.

Eydenzelt, a biosimilar to Eylea® (aflibercept), is designed to treat retinal disorders, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), macular edema due to retinal vein occlusion (RVO), and myopic choroidal neovascularisation (myopic CNV). Phase III trials demonstrated that Eydenzelt is therapeutically equivalent to Eylea, meeting rigorous efficacy, safety, pharmacokinetics, and immunogenicity standards in patients with DME. If approved by the European Commission (EC), Eydenzelt could become one of the first aflibercept biosimilars available in Europe.

Stoboclo (60 mg) and Osenvelt (120 mg), biosimilars referencing Prolia® and Xgeva®, respectively, have been recommended for approval for all indications of their reference products. Phase III studies in postmenopausal osteoporosis (PMO) confirmed that CT-P41 (denosumab) has comparable efficacy, pharmacokinetics, pharmacodynamics, and safety to the original drugs, with no significant differences observed.

Avtozma, a biosimilar to RoActemra® (tocilizumab), has been recommended for all approved uses of its reference product, including moderate to severe rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA), and giant cell arteritis (GCA). Comprehensive clinical evidence demonstrated that Avtozma delivers equivalent efficacy, safety, and pharmacokinetics, with no clinically meaningful differences from RoActemra.

Taehun Ha, Vice President and Head of Europe at Celltrion, said in a statement, “With CHMP approvals for Eydenzelt, Avtozma, and Prolia/Xgeva biosimilars, Celltrion solidifies its leadership in the European biosimilar market, offering one of the most extensive antibody biosimilar portfolios. Our vertically integrated model ensures supply chain stability while addressing European healthcare professionals and patients' specific challenges. These approvals underscore our commitment to supporting European healthcare systems by improving access to affordable treatments. Our focus remains on empowering clinicians with the tools and solutions they need as we aim to transition from a pioneer to a frontier leader in European healthcare.”

The CHMP’s recommendations will now be reviewed by the European Commission, which will decide on granting marketing authorisations. If approved, the biosimilars will be available across EU member states. This will reinforce Celltrion’s commitment to expanding access to adequate and affordable healthcare solutions.