Amgen's Stelara-Based Biosimilar Shows Comparable Efficacy, Safety Profile For Psoriasis

Amgen Inc AMGN announced preliminary results from a Phase 3 study of ABP 654 compared to Janssen Biotech Inc's Stelara (ustekinumab) in 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.
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ABP 654 is being developed as a biosimilar candidate to Stelara, a human interleukin-12 and interleukin-23 antagonist indicated for plaque psoriasis in adults and pediatric patients, adult patients with moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis.
Price Action: AMGN shares closed 0.08% higher at $252.12 during after-hours trading on Monday.