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Recent highlights
Celltrion announces U.S. availability of AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation
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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 interchangeability (IC) designation applies to prefilled syringe (40mg) and autoinjectors (40mg and 80mg)INCHEON, South Korea, May 23, 2025 /– Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has […]
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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 commitment to advancing scientific understanding in the field of IBD INCHEON, South Korea, April 28, 2025 — Celltrion, Inc. today announced that six abstracts […]
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U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab)
· YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar, that is now interchangeable [1] · Interchangeable designation of YUFLYMA® is supported by positive data from the Phase III interchangeability study in patients with moderate-to-severe plaque psoriasis INCHEON, South Korea, April 14, 2025 /– Celltrion, Inc. today announced that the U.S. Food and Drug […]
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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 2024JERSEY CITY, N.J., March 27, 2025 – Celltrion, Inc., today announced that STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab) has been added to the Costco Member Prescription Program. “We’re […]
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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 improve patient access to high-quality biologic treatments[1]· With […]
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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 the FDA· 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 availability of the first omalizumab biosimilar will help increase access and potentially lower the healthcare cost for people with asthma […]
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