Biosimilar Candidate to Ustekinumab Shows Positive Results Treating Plaque Psoriasis

A phase 3 study evaluating the efficacy and safety of biosimilar ABP 654 compared to the reference product ustekinumab (Stelara; Amgen) in adult patients with moderate to severe plaque psoriasis met the primary efficacy endpoint and demonstrated no clinically meaningful differences between the biosimilar and ustekinumab.

The phase 3, multicenter, randomized, double-blinded, comparative clinical study was evaluating the efficacy and safety of ABP 654 compared with ustekinumab in adult patients with moderate to severe plaque psoriasis. The study randomized 563 patients, with 281 patients in the ABP 654 group and 282 patients in the ustekinumab group.

The analysis evaluated the percentage improvement from baseline to week 12 of psoriasis area severity index (PASI), which showed a mean difference of percentage improvement between ABP 654 and ustekinumab of 0.14, which was within prespecified margins, according to the study.

"Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines," said David M. Reese, MD, executive vice president of Research and Development at Amgen, in a press release. "We look forward to continuing to expand our inflammation portfolio to offer patients a variety of treatment options."

Ustekinumab is a commonly used biologic therapy for the treatment of moderate to severe plaque psoriasis. The drug is administered subcutaneously based on weight at 45 mg for patients weighing ≤100 kg (220 lbs) and 90 mg for patients >100 kg, with the first 2 doses 4 weeks apart followed by a dose every 12 weeks.

ABP 654 is currently being developed as a biosimilar candidate to ustekinumab, which is an approved human interleukin (IL)-12 and IL-23 agonist indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients who are candidates for phototherapy or systemic therapy, active psoriatic arthritis in adults, and adult patients with moderately to severely active Crohn disease and moderately to severely active ulcerative colitis.

REFERENCE

AMGEN announces positive top-line results from phase 3 study of ABP 654, biosimilar candidate to STELARA® (ustekinumab). Amgen. April 18, 2022. Accessed April 19, 2022. https://www.amgen.com/newsroom/press-releases/2022/04/amgen-announces-positive-topline-results-from-phase-3-study-of-abp-654-biosimilar-candidate-to-stelara-ustekinumab