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Recent highlights
Celltrion announces U.S. availability of AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation
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Celltrion presents innovative drug pipeline and U.S. manufacturing and R&D expansion strategy at the 44th Annual J.P. Morgan Healthcare Conference
– Celltrion outlines a blueprint for innovative drug development built on its antibody expertise- The company highlights its business strategy to scale U.S. manufacturing and R&D capabilities, strengthening its global supply chain, production and operationsINCHEON, South Korea, Jan. 13, 2026 /PRNewswire/ — Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today presented key strategic priorities and clinical […]
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Celltrion to present at the 44th Annual J.P. Morgan Healthcare Conference
INCHEON, South Korea, Jan. 6, 2026 – Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today announced that Jin-Seok Seo, Chief Executive Officer and Hyuk-Jae Lee, Senior Executive Vice President at Celltrion, will present at the 44th Annual J.P. Morgan Healthcare Conference taking place in San Francisco, California on January 12–15, 2026.Celltrion’s presentation and fireside chat are scheduled for Tuesday, January 13, […]
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Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®
– FDA approval of OMLYCLO® (omalizumab-igec) 300 mg/2 mL solution in a single-dose prefilled syringe for subcutaneous injection expands dosing flexibility and supports tailored treatment for individual patients with certain allergic diseases- OMLYCLO® (omalizumab-igec) is the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab); The FDA previously approved OMLYCLO® 75 mg/0.5 mL and 150 mg/mL in a […]
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Celltrion announces publication of post-hoc analysis of LIBERTY-CD study of ZYMFENTRA® (infliximab-dyyb), indicating consistent efficacy across disease location, including the terminal ileum in Clinical Gastroenterology and Hepatology journal
– Findings from the post-hoc analysis of LIBERTY-CD study indicates efficacy of ZYMFENTRA® (subcutaneous infliximab) regardless of disease location, consistent across ileum-dominant and colon-dominant Crohn’s disease (CD)- Findings support the therapeutic potential of ZYMFENTRA in addressing persistent treatment gaps especially in ileum-dominant CDINCHEON, South Korea, Nov. 26, 2025 /PRNewswire/ — Celltrion, Inc. today announced that a post-hoc analysis of the […]
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U.S. FDA grants interchangeability designation to Celltrion's denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo)
– The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable with the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications, effective as of October 29, 2025- The interchangeability (IC) designations of STOBOCLO and OSENVELT were granted based not only on the comparative clinical data – including pharmacokinetics, efficacy, safety and an immunogenicity study in postmenopausal women with […]
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FDA approves expanded pediatric indications for YUFLYMA® (adalimumab-aaty) and unbranded adalimumab-aaty in the United States
– YUFLYMA® (adalimumab-aaty), and its unbranded version, are now approved for two additional pediatric indications – adolescent hidradenitis suppurativa (HS) and pediatric uveitis (UV), in the U.S. [1] , [2]- Pediatric UV is a rare eye inflammation in children, representing 5–10% of all uveitis cases in the U.S., while HS affects approximately 1–4% of the U.S. population [3] , [4]- Celltrion strengthens and […]
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