Publications

Authors:

Hee Cheona, Jae; B, Byong Duk Ye; Armuzzi, Alessandro; Riedere, Florian; Girolomoni, Giampiero; Puig, Luis; Jungh, Hojung; Feldmani, Steven R.

Title:

The ‘totality of evidence’ and ‘extrapolation’ of SB17, a ustekinumab biosimilar

Year:

2025

Type of item:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Language:

Inglese

Referee:

No

Name of journal:

EXPERT OPINION ON BIOLOGICAL THERAPY

ISSN of journal:

1744-7682

Page numbers:

615-632

Keyword:

Biosimilar; crohn’s disease; psoriasis; psoriatic arthritis; SB17; totality of evidence; ulcerative colitis; ustekinumab

Short description of contents:

Introduction: SB17 is a ustekinumab (UST) biosimilar targeting interleukin-12/23 for treating immune- mediated inflammatory diseases (IMIDs). The development of UST biosimilars like SB17 may help address the high cost of innovator biologics, offering affordable alternatives without compromising efficacy or safety. Areas covered: This review encompasses the totality of evidence supporting SB17’s similarity to UST, its regulatory approval, and indication extrapolation. It also discusses SB17’s lower immunogenicity relative to UST. Expert opinion: The approval of UST biosimilars represents a significant advancement in managing chronic IMIDs including psoriasis, plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, providing cost-effective, efficacious alternatives. A randomized double-blind 28-week study involving over 500 patients with moderate-to-severe chronic plaque psoriasis demonstrated SB17’s equivalence to UST, with more than 80% of patients achieving over 90% improvement in psoriasis severity indices. Treatment-emergent adverse events were comparable between SB17 and UST. Despite their potential to transform clinical outcomes, economic burdens, and drug utilization patterns, the adoption of UST biosimilars faces challenges, including concerns about equivalence and regulatory inconsistencies. Addressing these issues through education, consistent regulatory frameworks, real- world data, and ongoing monitoring is crucial for their successful integration into clinical practice.

Product ID:

146310

Handle IRIS:

11562/1165087

Last Modified:

June 19, 2025

Bibliographic citation:

Hee Cheona, Jae; B, Byong Duk Ye; Armuzzi, Alessandro; Riedere, Florian; Girolomoni, Giampiero; Puig, Luis; Jungh, Hojung; Feldmani, Steven R., The ‘totality of evidence’ and ‘extrapolation’ of SB17, a ustekinumab biosimilar «EXPERT OPINION ON BIOLOGICAL THERAPY» , 2025 , pp. 615-632

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