“Celltrion is committed to expanding access to high-quality monoclonal antibody treatments for patients across Europe,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “Securing regulatory approval for three biosimilar products on the same day highlights our commitment to providing healthcare professionals with reliable, effective, and accessible treatment options for their patients. With a portfolio of 11 biosimilar brands and a fully integrated approach—from research and development to manufacturing and direct supply—Celltrion is increasing treatment options, improving patient access to biologics, and strengthening its role as a trusted partner for healthcare professionals in Europe, all while supporting the sustainability of healthcare systems.”

Data showed that Eydenzelt^® (40 mg/mL solution for injection in vial and pre-filled syringe), Stoboclo^® (60 mg solution for injection in pre-filled syringe) and Osenvelt^® (120 mg solution for injection in vial) have comparable quality, safety and efficacy when compared to their respective reference products, Eylea^® (aflibercept) and Prolia^® and Xgeva^® (denosumab), respectively. ^1,2,3

“The European Commission approval of Eydenzelt^®, Stoboclo^® and Osenvelt^® are a significant milestone and a welcome addition to our portfolio of medicines to address a significant unmet need in therapeutic areas including skeletal-related disorders and ophthalmology,” said Min Kyoung Jeon, Vice President and Head of Regulatory Affairs Division at Celltrion. “The approval highlights Celltrion’s continuous commitment to expanding the availability, access and uptake of these important treatment options to patients with unmet needs.”

The company’s therapeutics include a total of 11 biosimilar products: 4 immunology products, including Remsima^®/Inflectra^® (US), Remsima^® SC, Yuflyma^®, and SteQeyma^®; 3 oncology products, including Truxima^®, Herzuma^®, and Vegzelma^®; and other therapeutic areas, including Omlyclo^®, Eydenzelt^®, Stoboclo^® and Osenvelt^®.