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 ...
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 ofOctober 29, 2025 * The interchangeability (IC) designations o...
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...
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...
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 stre...
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's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths
* YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1] * Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled syringes (20mg & 80mg); Expanded interchangeabilit...
/DISREGARD RELEASE: Celltrion/
We are advised by Celltrion that journalists and other readers should disregard the news release, Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths, issued21-May-2025 over PR Newswire. ...
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...
Celltrion's STEQEYMA® (ustekinumab-stba), now added to the Costco Member Prescription Program
* STEQEYMA® (ustekinumab-stba) is Celltrion's biosimilar to STELARA® (ustekinumab), which was launched onMarch 12, 2025 * Celltrion's adalimumab-aaty was previously added to the Costco Member Prescription Program inAugust 2024 JERSEY CITY, N.J., March 27, 2025 /PRNewswire/ -- Celltrion, Inc.,...
STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), now available in the United States
* STEQEYMA®, one of the first-wave biosimilars to STELARA®, is now available in the U.S. * Approved for the same indications as the reference product, STEQEYMA will be priced with a wholesale acquisition cost (WAC) list price at an 85% discount to the current WAC list price of STELARA to help...
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 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 ...
U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab)
* STEQEYMA (CT-P43) is approved for both adult and pediatric patients with plaque psoriasis (PsO) and active psoriatic arthritis (PsA) as well as adults with Crohn's disease (CD) and ulcerative colitis (UC) * STEQEYMA is a strategic addition to Celltrion's portfolio, expanding the portfolio a...
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...
/DISREGARD RELEASE: Celltrion USA/
We are advised by Celltrion USA that journalists and other readers should disregard the news release, CelltrionUSA partners with Express Scripts and Cigna Healthcare to expand access to ZYMFENTRA® (infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab on their medical benefit ...
Celltrion USA announces incorporation of adalimumab-aaty, a Humira® biosimilar, to the Costco Member Prescription Program
* Adalimumab-aaty was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available among key distributors across the U.S. onJuly 2, 2023 * Adalimumab-aaty's inclusion creates greater accessibility to treatments for Americans with inflammatory conditions...
