Celltrion Expands Pediatric Options with New STEQEYMA® Presentation Approval

Celltrion's Latest FDA Approval for STEQEYMA®

On June 15, 2025, Celltrion, Inc. announced the U.S. Food and Drug Administration (FDA) granted approval for a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar of STELARA® (ustekinumab). This new option is a 45mg/0.5mL solution available in a single-dose vial designed specifically for subcutaneous injection. Importantly, this approval enhances the flexibility in dosing for pediatric patients aged between 6 to 17 years who weigh less than 60kg and are diagnosed with plaque psoriasis (PsO) or psoriatic arthritis (PsA).

Previously, STEQEYMA had been approved in different forms such as a 45mg/0.5mL and 90mg/mL solution in a single-dose prefilled syringe and a 130mg/26mL intravenous infusion vial. With the addition of this new vial option, STEQEYMA is now fully aligned with the dosage forms and strengths of its reference product, STELARA®, thereby enhancing treatment options for doctors and their young patients.

Hetal Patel, PharmD MBA, the Vice President of Medical Affairs at Celltrion USA, highlighted the complexities involved in managing inflammatory diseases among pediatric patients. The introduction of this new presentation not only provides much-needed flexibility but also supports continuity of care, ensuring these young patients have reliable treatment options that are crucial for their health management.

Celltrion’s Chief Commercial Officer, Thomas Nusbickel, expressed pride regarding the new presentation of STEQEYMA. He reiterated that this approval underscores the company's commitment to expanding access to effective treatments for all patients, particularly those in the pediatric demographic facing chronic inflammatory conditions. As a leader in immunology, Celltrion strives to guarantee accessible, high-quality treatment options across their entire patient population.

The FDA's decision to approve STEQEYMA was based upon comprehensive evidence, which included results from a phase III clinical study involving adults diagnosed with moderate to severe plaque psoriasis. In this study, the rate of change in the Psoriasis Area and Severity Index (PASI) served as the primary endpoint. Findings confirmed that STEQEYMA is highly similar to its reference counterpart, with no significant differences in terms of safety and efficacy.

Furthermore, the FDA has provided STEQEYMA with full interchangeability designation with STELARA for all its indications, following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025. This designation offers healthcare providers greater confidence in prescribing the biosimilar without concern for eve differences in clinical outcomes.

In summary, the recent approval of STEQEYMA presents a pivotal advancement in the treatment landscape for pediatric conditions such as psoriasis and psoriatic arthritis. As healthcare continues to evolve, ensuring access to reliable and effective treatment options remains a priority—especially for vulnerable populations like children.

About STEQEYMA® (ustekinumab-stba)

STEQEYMA® is a human IL-12 and -23 antagonist that treats various immune-mediated conditions, aligning closely with the indications approved for the STELARA® reference product. These indications encompass moderate to severe plaque psoriasis in patients aged 6 and above, active psoriatic arthritis, as well as Crohn's disease and ulcerative colitis in adult patients.

Relevant Safety Information

While STEQEYMA provides promising therapeutic options, it is essential to note that the treatment is contraindicated for patients with significant hypersensitivity to its components. It may also elevate the risk of serious infections and malignancies; therefore, close monitoring and appropriate diagnostic testing are advised prior to commencing treatment. Among the common adverse effects observed in clinical trials were nasopharyngitis, upper respiratory infections, and fatigue.

About Celltrion

Celltrion is a recognized biopharmaceutical company innovating in therapeutic research and development, and manufacturing of biosimilars and novel drugs. The company has a significant role in providing high-quality medications across a range of therapeutic areas including immunology, oncology, and hematology. Focused on patients’ health needs, Celltrion continues to push the boundaries of biotechnology and improve access to essential treatments worldwide.