Tagged as: Stelara

FDA Approves Celltrion’s New Pediatric Formulation of STEQEYMA, Expanding Dosing Flexibility

On June 15, 2025, Celltrion announced that the FDA has approved a new 45mg/0.5mL single-dose vial presentation of STEQEYMA (ustekinumab-stba) for subcutaneous injection.  The formulation is intended for pediatric patients (ages 6–17) under 60kg with plaque psoriasis (PsO) or psoriatic arthritis (PsA).  With this approval, STEQEYMA now matches all dosage…

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Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI (ustekinumab-aekn) with STELARA (ustekinumab)

On May 5, 2025, Teva and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SELARSDI (ustekinumab-aekn) injection as an interchangeable biosimilar to the reference product STELARA (ustekinumab).  SELARSDI is approved for all indications matching the reference product, including for the treatment of moderate to severe plaque psoriasis…

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District of New Jersey Denies Preliminary Injunction in Ustekinumab Breach of Contract Case

On April 28, the U.S. District Court for the District of New Jersey denied Janssen Biotech, Inc. (“Janssen”) and Johnson & Johnson’s motion for a preliminary injunction seeking to enjoin Samsung Bioepis Co. Ltd. (“Samsung”) from launching a private label biosimilar of Janssen’s STELARA® (ustekinumab) in a breach of contract…

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Commercialization of Ustekinumab and Golimumab Biosimilars

This Monday, Bio-Thera Solutions and Dr. Reddy’s Laboratories SA announced that they had entered into commercialization and licensing agreements for proposed ustekinumab and golimumab biosimilars in Southeast Asia.  Bio-Thera will develop, manufacture, and supply BAT2206 (the proposed ustekinumab biosimilar referencing Janssen’s STELARA) and BAT2506 (the proposed golimumab biosimilar referencing Janssen’s…

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