Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

Shots: Celltrion has launched Osenvelt & Stoboclo, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the US Stoboclo (60mg/mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase inhibitors…

ByRidhi RastogiJuly 8, 2025

NEWS

The US FDA Approves Additional Presentation of Celltrion’s Steqeyma (Biosimilar, Stelara)

Shots: The US FDA has approved Steqeyma (45mg/0.5mL, SC, single-dose vial), a biosimilar version of Stelara (ustekinumab) for the treatment of pts (6-17yrs.; ≤60kg) with plaque PsO or PsA Approval was supported by extensive clinical data, incl. P-III trial of Steqeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change…

ByRidhi RastogiJune 16, 2025

NEWS

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots: FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringes Designation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev.…

ByRidhi RastogiMay 22, 2025

NEWS

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) Designation was backed by P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was…

ByRidhi RastogiApril 15, 2025

NEWS

Celltrion’s Steqeyma (Biosimilar, Stelara) Adds into the Costco Member Prescription Program

Shots: Celltrion announced that Steqeyma (ustekinumab-stba), a biosimilar to Stelara, has been added to the Costco Member Prescription Program. It was launched on Mar 12, 2025. Celltrion's adalimumab-aaty was added to the program in Aug 2024 Steqeyma will be available in the US from Costco Specialty Pharmacies on Apr 1, 2025, for self-funded employer plans,…

ByDipanshu DixitMarch 28, 2025

NEWS

Celltrion Launches Remdantry (Biosimilar, Remicade) Across Canada

Shots: Celltrion has launched Remdantry (formerly Inflectra) injection, a biosimilar to Remicade (infliximab), which will be launched on April 1, 2025, in Canada & received Health Canada NOC on March 7, 2025 Remdantry, consisting of a chimeric IgG1 mAb that binds to human TNFα, will share the same DIN as Inflectra. It was approved by…

ByDipanshu DixitMarch 28, 2025

NEWS

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Shots: Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024 Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin…

ByRidhi RastogiMarch 17, 2025

NEWS

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

Shots: The US FDA has approved & granted interchangeability designation to Omlyclo, a biosimilar to Xolair (omalizumab) for the treatment of mod. to sev. persistent asthma, CRSwNP, IgE-mediated food allergy, & chronic spontaneous urticaria (CSU) Approval was based on multiple clinical evidence, incl. P-III trial assessing Omlyclo (150mg, Q4W) vs Xolair (300mg, Q4W) in…

ByDipanshu DixitMarch 10, 2025

NEWS

Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products Approval is based on P-III trial results in postmenopausal women with osteoporosis, which showed equivalent efficacy & PD of CT-P41 to reference denosumab, with similar PK and comparable safety, and…

ByRidhi RastogiMarch 5, 2025

NEWS

Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)

Shots: Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev.…

ByRidhi RastogiFebruary 24, 2025

Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

The US FDA Approves Additional Presentation of Celltrion’s Steqeyma (Biosimilar, Stelara)

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation

Celltrion’s Steqeyma (Biosimilar, Stelara) Adds into the Costco Member Prescription Program

Celltrion Launches Remdantry (Biosimilar, Remicade) Across Canada

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)

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