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®...
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...
WellsCare Partners with Celltrion Canada to Bring Advanced Wearable Pain Relief Tech to North America
SEOUL, South Korea, Oct. 20, 2025 /PRNewswire/ -- WellsCare, a South Korean medical technology startup, announced that on October 9, it signed a Memorandum of Understanding (MOU) with Celltrion Canada, a subsidiary of the global biopharmaceutical...
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...
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,...
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...
Hyundai ADM Bio Voluntarily Withdraws IND for Clinical Study of Docetaxel Combination Cancer Therapy to Focus on Immunotherapy Strategy
Declares a strategic pivot to lead the post-patent immunotherapy combination era SEOUL, South Korea, May 13, 2025 /PRNewswire/ -- Hyundai ADM Bio (KOSDAQ symbol 187660) today announced the voluntary withdrawal of its Investigational New Drug (IND)...
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...
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 on March 12, 2025 Celltrion's adalimumab-aaty was previously added to the Costco Member Prescription Program in August 2024 JERSEY CITY, N.J., March...
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...