Amgen (AMGN) Announces Positive Top-line Results From Phase 3 Study Of Abp 654, Biosimilar Candidate To Stelara

Amgen (NASDAQ: AMGN) today 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. 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.

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

ABP 654 is being developed as a biosimilar candidate to STELARA, an approved 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.

Amgen has a total of 11 biosimilars in its portfolio, including five that have been approved by the U.S. Food and Drug Administration (FDA) and three that are approved in the EU.

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