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 PsAApproval 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…
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,…
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 2024Approval 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…
Shots: Celltrion has receive the US FDA’s approval for Steqeyma, biosimilar version of J&J’s Stelara (ustekinumab), to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, & ulcerative colitis The approval was supported by P-III study in mod. to sev. plaque psoriasis with 1EP as change in the PASI for skin symptoms, showing therapeutic equivalence b/w Steqeyma…
Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients The major highlights were the US FDA’s approval of Sandoz’s Enzeevu for Treating Neovascular Age-Related…
Shots: Following the CHMP’s positive opinion in Jun 2024, the EC has approved SteQeyma, a biosimilar version of Stelara (ustekinumab), for treating various chronic inflammatory diseases. Approved as biologic for gastroenterology, dermatology & rheumatology indications Approval was supported by the P-III trial of SteQeyma vs Stelara for moderate to severe plaque PsO, with 1EP as…
Shots: Health Canada has approved Steqeyma injection & Steqeyma I.V. (injection, solution for IV infusion), biosimilar versions of Stelara (ustekinumab) to treat adults with moderate to severe active Crohn’s disease & plaque PsO as well as active psoriatic arthritis Approval was supported by the P-III trial of Steqeyma vs Stelara, with the 1EP as rate…

