Celltrion announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for three of its biosimilar candidates: Eydenzelt® (CT-P42, aflibercept), Stoboclo® and Osenvelt® (CT-P41, denosumab), and Avtozma® (CT-P47, tocilizumab). These recommendations highlight Celltrion’s leadership in biosimilar innovation and its commitment to increasing access to biologic therapies across Europe.
Eydenzelt® (40 mg/mL solution for injection) is a biosimilar to Eylea® (aflibercept), and has been recommended for approval to treat retinal disorders such as age-related macular degeneration (AMD), diabetic macular edema (DME), and other conditions. A Phase 3 study showed Eydenzelt’s therapeutic equivalence to Eylea, meeting predefined equivalence criteria. If approved by the European Commission (EC), Eydenzelt will be one of the first aflibercept biosimilars in Europe.
Stoboclo® (60 mg pre-filled syringe) and Osenvelt® (120 mg vial) have been recommended for approval for all indications of the reference products Prolia® and Xgeva®, respectively. The CHMP’s decision was supported by Phase III data showing that CT-P41 demonstrated equivalent efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and safety to the reference products.
Avtozma®, a biosimilar referencing RoActemra® (tocilizumab), has been recommended for approval for conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, and giant cell arteritis. The positive opinion was based on robust clinical trial data showing that Avtozma is clinically similar to RoActemra, with no significant differences in efficacy, PK, safety, or immunogenicity.
Celltrion’s Vice President, Taehun Ha, emphasized that these approvals solidify the company’s leadership in Europe’s biosimilar market, offering a diverse portfolio of antibody biosimilars. He also noted that Celltrion’s vertically integrated model ensures a stable supply chain, addressing the needs of European healthcare professionals and patients.
The CHMP opinions will now be forwarded to the European Commission for a final decision on the marketing authorizations. If granted, the biosimilars will be available in all EU member states, further strengthening Celltrion’s presence in the European healthcare market.
About the Biosimilar Candidates:
- Eydenzelt® (CT-P42): A biosimilar to Eylea® for retinal disorders, supported by Phase III data demonstrating equivalence.
- Stoboclo® (CT-P41): A denosumab biosimilar for osteoporosis, recommended for approval for all indications of Prolia®.
- Osenvelt® (CT-P41): A denosumab biosimilar for skeletal-related events and giant cell tumors, recommended for approval for all indications of Xgeva®.
- Avtozma® (CT-P47): A tocilizumab biosimilar for rheumatoid arthritis and related conditions, supported by Phase III data showing equivalence to RoActemra®.
About Celltrion
Celltrion, based in Incheon, South Korea, is a global biopharmaceutical leader specializing in the research, development, and commercialization of biosimilars, including widely used products like Remsima®, Truxima®, and Herzuma®. The company’s commitment to providing affordable, high-quality treatments continues to strengthen its position in global healthcare markets.
