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 […]
Tag: Celltrion
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 […]
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 […]
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 […]
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 […]










