Blog Big Molecule Watch April 22, 2022

Amgen Announces Positive Results for Phase 3 Study of Ustekinumab Biosimilar

Amgen recently announced preliminary results from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA (ustekinumab) in adult patients with moderate to severe plaque psoriasis.  According to Amgen, the “study met the primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and STELARA.”  ABP 654 is a biosimilar of STELARA, a human interleukin-12 and interleukin-23 antagonist indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients (6 years or older) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis in adults, as well as for adult patients with moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis.

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