Amgen's Stelara Biosimilar ABP 654 Meets Primary Endpoint in Phase 3 Trial

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Recently, Amgen announced preliminary results from a Phase 3 clinical study. This was a multicenter, randomized, double-blind, comparative clinical study (Study Number: 04607980) conducted in adult patients with moderate to severe plaque psoriasis, evaluating the efficacy and safety of the biosimilar ABP 654 compared to Stelara (ustekinumab).

The study enrolled a total of 563 patients, with 281 in the ABP 654 treatment group and 282 in the Stelara treatment group. The results showed that the study met its primary efficacy endpoint: there was no clinically meaningful difference between ABP 654 and Stelara. This initial assessment analyzed the percentage improvement in the Psoriasis Area and Severity Index (PASI) from baseline to week 12 of treatment. The data showed that the mean difference in the percentage improvement of PASI between ABP 654 and Stelara was 0.14, which was within the pre-specified margin. The safety profiles of ABP 654 and Stelara were comparable.

Currently, ABP 654 is being developed as a biosimilar to Stelara, with the same formulation, dosage strength, route of administration, and dosing regimen as Stelara.

Stelara is an older anti-inflammatory drug from Johnson & Johnson. It is the world's first biologic that can simultaneously and selectively target IL-12 and IL-23. IL-12 and IL-23 are two naturally occurring cytokines that play a key role in immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and more. Stelara works by binding with high affinity to the shared p40 subunit of IL-12 and IL-23, preventing their interaction with cell surface receptors, thereby disrupting IL-12 and IL-23 mediated signaling and cytokine effects.

According to reports, Stelara was launched in 2009 and has been approved for various indications, including: (1) adult and pediatric patients (≥6 years old) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; (2) treatment of adult patients with active psoriatic arthritis; (3) treatment of adult patients with moderate to severe active Crohn's disease; (4) treatment of adult patients with moderate to severe active ulcerative colitis.

Notably, Stelara plays a pivotal role in Johnson & Johnson's pharmaceutical business segment. According to the company's financial report, Stelara's global sales reached $9.134 billion in 2021, representing an 18.5% increase from the previous year and accounting for 28% of its entire pharmaceutical business. However, Stelara's primary patent in the U.S. is set to expire in 2023, and several companies are currently developing related biosimilars.

Reference Source: AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 654, BIOSIMILAR CANDIDATE TO STELARA® (USTEKINUMAB)