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Benzinga
Benzinga
Technology
Vandana Singh

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

  • Amgen Inc (NASDAQ: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.
  • Also Read: Amgen's Lumakras Shows Two-Year Overall Survival Of 32.5% In KRAS-Mutated Lung Cancer.
  • 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.
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