FDA Approves Celltrion’s Stelara Biosimilar for Multiple Indications

Image Credit: Adobe Stock Images/kasia2003

The FDA has approved Celltrion’s Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for subcutaneous or intravenous use in adults and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn disease and ulcerative colitis. According to the company, the approval was based on a comprehensive evidence review, including a Phase III trial in moderate to severe plaque psoriasis, demonstrating comparable safety, efficacy, and clinical performance to Stelara.¹

"The approval of Steqeyma reflects Celltrion's continued investment in providing treatment options to patients diagnosed with ulcerative colitis, Crohn's disease, psoriasis, and psoriatic arthritis," said Thomas Nusbickel, chief commercial officer, Celltrion USA, in a press release. "Steqeyma is now the latest biologic in our immunology portfolio, joining Zymfentra((infliximab-dyyb). Our portfolio, supported by our fully integrated platform, establishes Celltrion USA as an important player in the US immunology market."

Steqyma is a human interleukin (IL)-12 and IL-23 antagonist that encompasses all indications that are currently approved for Stelara. The treatment is available in both subcutaneous (SC) and intravenous (IV) formulations, with the SC injection including either 45 mg/0.5 mL or 90 mg/1 mL in a single-dose, prefilled syringe, and the IV infusion including a 130 mg/26 mL in a single-dose vial.¹

According to the National Psoriasis Foundation, over eight million people in the United States are currently living with psoriasis. Additionally, an estimated 125 million people globally are currently living with the condition. Around 30% of people with psoriasis also develop psoriatic arthritis, which has a prevalence of 1.5% in African Americans and 3.6% in Caucasians. Around 60% of people in the United States also report that it has caused significant problems in their everyday life.

While psoriasis can occur at any age, it is most common between 20 and 30 years of age in the first peak onset, and between 50 and 60 years of age for the second peak onset. In most cases, it develops between 30 and 50 years of age. In the United States, healthcare costs related to psoriasis account for $135 billion annually, mainly due to considerably negative physical, psychiatric, and social consequences.²

According to MedLine Plus, Crohn disease most common in western Europe and North America, where it has a prevalence of 100 to 300 per 100,000 people. Over 500,000 people in the United States are currently living with the condition. Crohn disease occurs more often in people of northern European ancestry and those of eastern and central European ancestry. While it is currently unknown as to why, the prevalence of Crohn disease has been increasing in the United States and some other parts of the world. Approximately 15% of all people living with Crohn disease have a first-degree relative with the disorder.³

"Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin and present differently in all patients," said Mark G. Lebwohl, MD, Icahn School of Medicine at Mount Sinai, New York, in the press release. "The approval of new treatment option is welcome news for people living with certain chronic inflammatory conditions, such as psoriasis, which affect more than 3% of the US adult population."

Set to enter the US market in February 2025 under a settlement agreement with Johnson & Johnson, the manufacturer of the reference biologic, Celltrion stated that it is committed to expanding treatment options for chronic inflammatory diseases that are currently impacting millions in the United States.¹

References

1. U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab). PR Newswire. December 17, 2024. Accessed December 18, 2024. https://www.prnewswire.com/news-releases/us-fda-approves-celltrions-steqeyma-ustekinumab-stba-a-biosimilar-to-stelara-ustekinumab-302334458.html?tc=eml_cleartime

2. Psoriasis Statistics. NPF. Accessed December 18, 2024. https://www.psoriasis.org/psoriasis-statistics/

3. Crohn's disease. Medline Plus. Accessed December 18, 2024. https://medlineplus.gov/genetics/condition/crohns-disease/#causes