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 m...
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 r...
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 availa...
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 syrin...
Celltrion to present six abstracts in inflammatory bowel disease (IBD) at 2025 Digestive Disease Week® (DDW)
* Six abstracts accepted for presentation includes post hoc analyses and real-world evidence for ZYMFENTRA® (infliximab-dyyb) * Findings reinforce clinical decision-making in long-term management of moderate-to-severe Crohn's disease and ulcerative colitis and underscore Celltrion's commitmen...
U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
* OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by theFDA * Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® (omalizumab)[1] * The ava...
Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®
* STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1], [2] * The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences fr...
Celltrion unveils strategic vision for advancing its innovative drug pipeline at the 43rd Annual J.P. Morgan Healthcare Conference
* Celltrion unveils strategic roadmap for the first time outlining its innovative drug development strategy and its plan to submit 13 Investigational New Drug (IND) application by 2028 * Company reinforces its commitment to a two-pillar growth strategy focusing on its groundbreaking new drug ...
Celltrion presents additional data from phase III randomized controlled trials to further support biosimilarity for CT-41 (biosimilar candidate of denosumab) and CT-P47 (biosimilar candidate of tocilizumab) at American College of Rheumatology (ACR) Convergence 2024
* 78-Week results from Phase III randomized controlled trial (RCT) including switching data from reference denosumab to CT-P41 (biosimilar candidate of denosumab) demonstrate comparable efficacy and safety results; Results support the therapeutic equivalence of CT-P41 and reference denosumab in...
ZYMFENTRA® (infliximab-dyyb) coverage continues to increase through partnership with top 3 Pharmacy Benefit Managers (PBMs)
* Celltrion USA has expanded access to ZYMFENTRA® (infliximab-dyyb), the first and only FDA-approved subcutaneous (SC) infliximab, to a significant share of the U.S. market * The availability of ZYMFENTRA will support greater patient access and choice while helping to drive greater affordabil...
Celltrion presents post hoc analysis of LIBERTY studies of ZYMFENTRA® (infliximab-dyyb) at the American College of Gastroenterology 2024 Annual Scientific Meeting
* Pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) previously demonstrated superior efficacy of subcutaneous (SC) infliximab over placebo for maintenance therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC)[1], [2] * ZYMFENTRA® is the first and only FDA-approved subcut...
ZYMFENTRA™ (infliximab-dyyb) demonstrated long-term efficacy and safety profile of maintenance treatment through two years for adults with moderately to severely active Crohn's disease and ulcerative colitis
* Findings from the extended LIBERTY studies and associated post-hoc analysis support the long-term efficacy and safety of ZYMFENTRA™, the first and only FDA-approved subcutaneous infliximab[1],[2] * Data from a post-hoc analysis of the LIBERTY-CD study showed that, despite affecting drug lev...
Celltrion USA announces two-year data for ZYMFENTRA™(infliximab-dyyb) to be presented at Digestive Disease Week (DDW) 2024 Conference
* Data presentations including the extended LIBERTY studies to highlight the long-term treatment goals ofZYMFENTRA™, the first and only FDA-approved subcutaneous infliximab * The data underscores Celltrion's commitment to improving patient outcomes and advancing scientific understanding in th...
Celltrion USA's adalimumab-aaty biosimilar to HUMIRA® now available at low wholesale acquisition cost
* Adalimumab-aaty will be priced at an 85% discount to HUMIRA® (adalimumab) * Branded and unbranded versions of Celltrion USA's adalimumab biosimilar help provide more affordable options for patients JERSEY CITY, N.J., May 9, 2024 /PRNewswire/ -- CelltrionUSA announced today that adalimumab-aa...
