FDA nod for Celltrion's Steqeyma

The US Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Johnson & Johnson’s (NYSE: JNJ) Stelara, from South Korea’s Celltrion (Kosdaq: 068270).

The drug is indicated for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. The FDA nod adds to clearance for Steqeyma by the European regulator in August this year.

Celltrion noted that the FDA approval of Steqeyma was based on the totality of evidence, including the results from a phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that Steqeyma and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy.