FDA Approves Celltrion's STEQEYMA, a Biosimilar to STELARA

Celltrion has announced that the U.S. Food and Drug Administration (FDA) has approved STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), for the treatment of various immune-mediated diseases. This approval marks a significant milestone for Celltrion, as STEQEYMA is approved for both adults and children with plaque psoriasis (PsO) and active psoriatic arthritis (PsA), as well as adults with Crohn's disease (CD) and ulcerative colitis (UC). Celltrion plans to introduce STEQEYMA to the U.S. market in February 2025.

The approval of STEQEYMA was based on comprehensive evidence, including a phase III clinical study that evaluated its efficacy and safety in adult patients with moderate to severe plaque psoriasis. The primary measure of success was the change in the Psoriasis Area and Severity Index (PASI), and the results demonstrated that STEQEYMA was highly similar to its reference product, ustekinumab. There were no significant differences in safety and efficacy between the two, confirming STEQEYMA's potential as a viable treatment option.

Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, emphasized the company's dedication to expanding treatment options for patients suffering from chronic inflammatory conditions. He highlighted that STEQEYMA's addition to their portfolio strengthens Celltrion's presence in the U.S. immunology market. Dr. Mark G. Lebwohl from the Icahn School of Medicine at Mount Sinai, New York, praised the approval of new treatments like STEQEYMA, which are crucial for individuals battling chronic inflammatory diseases that affect a significant portion of the U.S. population.

STEQEYMA is a fully human monoclonal antibody that targets interleukin-12 (IL-12) and interleukin-23 (IL-23), important cytokines involved in inflammatory and immune responses. Celltrion reached a settlement and licensing agreement with Johnson & Johnson, the manufacturer of the reference biologic, which allows STEQEYMA's entry into the U.S. market in February 2025.

The medication is available in both subcutaneous and intravenous forms, with the subcutaneous injection offered in two strengths: 45mg/0.5 mL or 90mg/1 mL in a prefilled syringe. The intravenous formulation is provided as a 130mg/26 mL solution. STEQEYMA is indicated for treating moderate to severe plaque psoriasis in adults and children aged six and above, active psoriatic arthritis in the same age group, as well as moderately to severely active Crohn's disease and ulcerative colitis in adults.

While STEQEYMA provides a promising new treatment option, it's important to be aware of its safety profile. Patients with a significant hypersensitivity to ustekinumab products or its excipients should not use STEQEYMA. Additionally, there is an increased risk of serious infections, and patients should avoid starting the treatment during any active infection. Patients should also be assessed for tuberculosis prior to initiating treatment and monitored for malignancies, as there is a potential increased risk. If any severe hypersensitivity reactions or other significant side effects occur, discontinuing the use of STEQEYMA is advised.

Celltrion USA, established in 2018 and headquartered in New Jersey, aims to improve patient care by expanding access to innovative biologics in the U.S. The approval of STEQEYMA reflects this commitment, and Celltrion plans to leverage its expertise in biotechnology and supply chain excellence to provide high-quality biopharmaceuticals nationwide. With a global network spanning over 110 countries, Celltrion continues to focus on delivering cost-effective solutions to improve patient outcomes.