The US Food and Drug Administration (FDA) has approved a new presentation of Celltrion’s SteQeyma, an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat paediatric patients with plaque psoriasis (PsO) or psoriatic arthritis (PsA).
The drug is now authorised as a 45mg/0.5ml solution in a single-dose vial for subcutaneous injection in patients aged six to 17 years who weigh less than 60kg.
It is hoped that the approval, which means that SteQeyma now offers all dosage forms and strengths of its reference product, will help meet physicians’ clinical needs and support treatment continuity for patients.
Approximately 125 million people worldwide are affected by some form of psoriasis, a chronic inflammatory condition that typically affects the skin, nails and joints.
PsO occurs in up to 90% of psoriasis patients and is characterised by distinct round or oval plaques that are usually covered by silvery-white scales. PsA, which causes joint pain, swelling and stiffness, is less common, affecting around 30% of psoriasis patients.
The FDA’s decision comes six months after it approved SteQeyma 45mg/0.5ml and 90mg/ml in a single-dose prefilled syringe for subcutaneous injection, and SteQeyma 130mg/26ml in a single-dose vial for intravenous infusion.
The December authorisation applied to adult and paediatric patients aged six years and older with PsO and PsA, as well as adults with Crohn’s disease and ulcerative colitis.
Among the evidence supporting the regulator’s latest approval of SteQeyma were positive results from a phase 3 study in adults with moderate-to-severe PsO, in which Celltrion’s biosimilar and Stelara showed no clinically meaningful differences in terms of safety and efficacy.
Hetal Patel, vice president of medical affairs at Celltrion USA, said: “Managing inflammatory diseases in paediatric patients can be particularly complex.
“The new dosage form and strength of SteQeyma allow us to better meet the specific needs of young patients, giving physicians a valuable treatment option with flexibility, supported by a well-established safety and efficacy profile.”
Celltrion outlined that the FDA has also granted SteQeyma full interchangeability across all indications of Stelara, “following the expiration of exclusivity for the first interchangeable biosimilar on 30 April 2025”.