Celltrion Gains Positive CHMP Opinion for Three Biosimilars
Monday, December 16, 2024
Celltrion has announced 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 biosimilar candidates.
“Eydenzelt, a biosimilar to Eylea® (aflibercept), has been recommended for approval as a treatment for various retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), diabetic macular oedema (DME), macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularisation (myopic CNV).
The recommendation is based on data from a Phase III clinical trial that demonstrated therapeutic equivalence to the reference product in efficacy, safety, pharmacokinetics, and immunogenicity. If approved by the European Commission (EC), Eydenzelt would become one of the first aflibercept biosimilars available in Europe.”
“Stoboclo and Osenvelt, biosimilars to Prolia® and Xgeva® respectively, have also received positive CHMP opinions. Stoboclo is designed to treat osteoporosis in postmenopausal women and men at increased risk of fractures, as well as bone loss associated with hormone ablation therapy or long-term glucocorticoid use.
Osenvelt is intended for preventing skeletal-related events in adults with advanced malignancies involving bone and for treating giant cell tumour of bone in adults and skeletally mature adolescents. Phase III clinical trials confirmed the biosimilars’ equivalence in efficacy, pharmacokinetics, safety, and immunogenicity to their respective reference products.”
“Avtozma, referencing RoActemra® (tocilizumab), has been recommended for all indications covered by the reference product. These include moderate to severely active rheumatoid arthritis (RA), juvenile idiopathic polyarthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and giant cell arteritis (GCA).
The CHMP’s decision is supported by data from a Phase III trial that demonstrated no clinically meaningful differences in efficacy, pharmacokinetics, safety, or immunogenicity between Avtozma and the reference product.”
These include Eydenzelt® (CT-P42, aflibercept), Stoboclo® and Osenvelt® (CT-P41, denosumab), and Avtozma® (CT-P47, tocilizumab). This marks a significant milestone in the company's efforts to advance biosimilar innovation and improve access to biologic therapies across Europe.
The CHMP’s recommendations will now be reviewed by the EC, which will decide on marketing authorisations for Eydenzelt, Stoboclo, Osenvelt, and Avtozma.
Approval would enable the distribution of these biosimilars across EU member states, furthering Celltrion’s goal of delivering cost-effective, high-quality treatments to patients in Europe.
Source: celltrion.com
