News
Positive phase III study of ABP 654,a ustekinumab biosimilar.
Amgen announced preliminary results from a Phase III study evaluating the efficacy and safety of ABP 654 compared to Stelara (ustekinumab) in adult patients with moderate to severe plaque psoriasis.
The study met the primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and Stelara.
The primary 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 Stelara of 0.14, which was within the prespecified margins. The safety profile of ABP 654 was comparable to Stelara.
The patents on Stelara will expire in the US in September 2023 and in Europe in January 2024.
Condition: Psoriasis
Type: drug