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Recent highlights
Celltrion announces U.S. availability of AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation
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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 from the reference products· With the FDA approval of STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) Celltrion’s biosimilar portfolio continues to […]
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U.S. FDA approves Celltrion's AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA®
– The intravenous (IV) formulation of AVTOZMA® (tocilizumab-anoh) is expected to be available in the U.S. in August 2025- Approval was received for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19[1]- AVTOZMA® becomes Celltrion’s fifth immunology biologic and seventh biosimilar approved […]
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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 and building on Celltrion’s expertise in immunology- STEQEYMA is expected to be marketed in the […]
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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 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 treating postmenopausal women with osteoporosis (PMO)[1] – Data from the Phase III RCT showed comparable and sustained efficacy, safety […]
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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 affordability to patients and health care systemsJERSEY CITY, N.J., Oct. 31, 2024 – Celltrion USA […]
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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 subcutaneous infliximab- Late-breaking post hoc analysis of the LIBERTY studies suggests no meaningful differences in efficacy and safety outcomes […]
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