Celltrion expands biosimilar portfolio in the European Union following European Commission approval of two biosimilars

• Celltrion gains simultaneous regulatory approval of two monoclonal antibody biosimilars across three treatments – Eydenzelt^® (aflibercept), Stoboclo^® and Osenvelt^® (denosumab) in the EU market
• European Commission approval based on totality of evidence including extensive comparative analytical, pharmacokinetic and clinical data
• The company expands its biosimilar portfolio to 11 in 2025 as planned, further strengthening its commitment to a portfolio of 22 drugs by 2030

THURSDAY 20 FEBRUARY, 2025 - INCHEON, SOUTH KOREA – Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt^® (CT-P42, aflibercept), a biosimilar to 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); and Stoboclo^® and Osenvelt^® (CT-P41, denosumab), biosimilars referencing Prolia^® and Xgeva^® 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.

“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. ^{[i],[ii],[iii]}

“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^®.

[i] Sebastian Wolf et al., Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42 3.1. [EURETINA 2024, Abstract #CA24-2257-8397]. Available at: https://abstracts.euretina.org/2024/ca24-2257-8397/r/recxUD7DqYfFfjC7s [Last accessed February 2025].

[ii] Sebastian Wolf et al., Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase III Study. Available at: https://www.sciencedirect.com/science/article/pii/S2468653024003063 [Last accessed February 2025].

[iii] Reginster JY et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23. PMID: 39042292; PMCID: PMC11499533. Available at: https://pubmed.ncbi.nlm.nih.gov/39042292/ [Last accessed February 2025].