Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients

Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients

Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for pediatric patients with plaque psoriasis (PsO) or psoriatic arthritis (PsA) under 60kgThe FDA previously approved STEQEYMA® 45mg/0.5mL, 90mg/mL in a single-dose prefilled syringe for subcutaneous…

FDA Approves Ustekinumab-Stba, Biosimilar to Stelara, for Pediatric Patients With PsO or PsA

The subcutaneous infusion is indicated for pediatric patients aged 6 to 17 years who weigh less than 60 kg.

Biosimilar Manufacturers to Expand Offerings in Europe and Japan

On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. Samsung Bioepis announced a licensing, development, and commercialization agreement with NIPRO Corporation for multiple biosimilar candidates in Japan.  One of these candidates is SB17, a biosimilar of Janssen’s STELARA (ustekinumab).  Under the agreement, Samsung Bioepis will be responsible fo…

FDA approves new presentation of ustekinumab-stba biosimilar for plaque psoriasis, psoriatic arthritis

The approval for ustekinumab-stba now offers all dosage forms to the reference product, ustekinumab, and is indicated for patients aged 6 to 17 years.

Celltrion secures FDA nod for STEQEYMA® pediatric dosing

INCHEON, South Korea, June 16, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque…