Celltrion reveals FDA approval for new STEQEYMA® dosing option for children

Celltrion, Inc., headquartered in Incheon, South Korea, has announced the approval of a new formulation of its biosimilar product, STEQEYMA® (ustekinumab-stba), by the U.S. Food and Drug Administration (FDA). This new presentation is a 45mg/0.5mL solution in a single-dose vial designed for subcutaneous injection. It is specifically approved for pediatric patients between the ages of 6 and 17 who weigh less than 60kg and are diagnosed with plaque psoriasis (PsO) or psoriatic arthritis (PsA). The approval expands the available dosing options, making treatment more adaptable to the needs of younger patients.

STEQEYMA® is a biosimilar to STELARA® (ustekinumab), which is used for treating several immune-mediated diseases. With this new FDA approval, STEQEYMA now matches all dosage forms and strengths of STELARA®, providing more comprehensive treatment options. The product was previously approved in December 2024 for various formulations, including subcutaneous injections in both 45mg/0.5mL and 90mg/mL solutions, as well as a 130mg/26mL solution for intravenous infusion. These formulations cover adult and pediatric patients suffering from plaque psoriasis and psoriatic arthritis, and extend to adult patients with Crohn's disease and ulcerative colitis.

Celltrion USA's Vice President of Medical Affairs, Hetal Patel, emphasized the complexity of managing inflammatory diseases in pediatric patients. Patel highlighted the importance of the new dosage form and strength in meeting the specific needs of younger patients. By offering this flexibility, physicians can better tailor treatment plans while relying on the established safety and efficacy profile of STEQEYMA. Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, underscored the company's commitment to widening access for all patient demographics, including children over 6 years old with chronic inflammatory conditions. Nusbickel noted that the approval reinforces Celltrion's dedication to providing broader access and flexibility in care.

The FDA's decision to approve this new presentation was based on comprehensive evidence, including results from a phase III study involving adults with moderate to severe plaque psoriasis. The study assessed the changes in the Psoriasis Area and Severity Index (PASI) for skin symptoms, demonstrating that STEQEYMA is highly similar to its reference product, STELARA®, with no significant differences in terms of safety and efficacy.

Moreover, the FDA has granted STEQEYMA full interchangeability with STELARA across all its indications. This decision follows the expiration of exclusivity for the first interchangeable biosimilar in April 2025. This interchangeability allows for seamless transition between the biosimilar and the reference product without compromising treatment efficacy or safety, further enhancing the flexibility in treatment options for healthcare providers.

STEQEYMA®, previously known as CT-P43, is a human IL-12 and -23 antagonist approved for treating multiple immune-mediated diseases. It covers all indications approved for STELARA®, including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is available in both subcutaneous and intravenous formulations, catering to diverse patient needs and preferences. The subcutaneous injection options include a 45mg/0.5mL or 90mg/1mL solution in single-dose prefilled syringes, and a 45mg/0.5mL solution in a single-dose vial. The intravenous infusion comes in a 130mg/26mL solution in a single-dose vial.

This development marks a significant step for Celltrion in enhancing treatment options for pediatric patients with inflammatory conditions and aligns with the company's broader mission to improve access to effective biologic therapies.