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Our latest company updates, product launches, leadership announcements, and public statements.
Recent highlights
Celltrion announces U.S. availability of AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation
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Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept)
– EYDENZELT® is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR) – Celltrion plans to enter the U.S. ophthalmology market to meet diverse needs of patients suffering from various eye conditions INCHEON, South Korea, Oct. 9, 2025 – […]
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Celltrion launches AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in the United States
– The AVTOZMA ® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the FDA to treat the same conditions as the reference product ACTEMRA ® (tocilizumab)- AVTOZMA is Celltrion’s fifth immunology biologic and seventh biosimilar approved by the FDA- This launch strengthens Celltrion’s immunology portfolio beyond tumor-necrosis factor (TNF)-alpha and interleukin (IL)-12 and 23 inhibitors, to include an IL-6 inhibitor , broadening coverage […]
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FDA approves expanded indication for AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS)
– Approval of AVTOZMA® (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and pediatric patients aged 2 years and older with cytokine release syndrome (CRS) [1]- AVTOMZA received FDA approval in January 2025, for multiple inflammatory indications including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and […]
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Celltrion USA announces U.S. launch of denosumab biosimilars, STOBOCLO® and OSENVELT® (denosumab-bmwo)
– STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1],[2]- STOBOCLO and OSENVELT, among the first wave of biosimilars referencing PROLIA and XGEVA respectively, are commercially available in the U.S.- Celltrion further expands its portfolio, delivering cost-effective and high-quality biologic medicines to wider range of […]
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Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients
– Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for pediatric patients with plaque psoriasis (PsO) or psoriatic arthritis (PsA) under 60kg- The FDA previously approved STEQEYMA® 45mg/0.5mL, 90mg/mL in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in December 2024- STEQEYMA now […]
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Celltrion USA Announces Appointment of Dr. Juby Jacob-Nara, M.D as Senior Vice President and Chief Medical Officer
· Dr. Juby Jacob-Nara brings a wealth of medical and clinical development knowledge and extensive expertise across multiple therapeutic areas and will lead medical strategy at Celltrion USA JERSEY CITY, N.J., June 2, 2025 – Celltrion USA today announced the appointment of Dr. Juby Jacob-Nara, M.D. as Senior Vice President and Chief Medical Officer. […]
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