Ustekinumab Biosimilar Pipeline Development Service
Comprehensive Solutions for IL-12p40 x IL-23-Targeted Biosimilar Development
Creative Biolabs provides comprehensive Ustekinumab biosimilar development solutions, leveraging our specialized expertise in IL-12/IL-23 pathway modulation to deliver end-to-end support from target characterization through commercialization. Our integrated approach combines cutting-edge antibody engineering capabilities with a robust cytokine-targeting platform, enabling precise development of biosimilars that meet stringent regulatory requirements. We guide partners through critical phases including molecular characterization, cell line development, process optimization and analytical method validation, ensuring complete alignment with global biosimilar guidelines. With extensive experience in immunomodulatory biologics, we streamline the development pathway while maintaining rigorous scientific standards and regulatory compliance throughout the entire process from candidate selection to market approval.
- At a glance of Ustekinumab
Service Overview
Ustekinumab is a monoclonal antibody designed to neutralize the p40 subunit common to both IL-12 and IL-23, cytokines that play a central role in inflammatory and immune-related disorders. By inhibiting these interleukins, it suppresses the activity of Th1 and Th17 pathways, thereby alleviating symptoms in diseases like psoriasis, psoriatic arthritis, and Crohn's disease. Globally approved, this biologic stands out for its sustained therapeutic effect and extended dosing intervals. Although adverse events such as infections or localized injection reactions may occur, its safety profile remains favorable. Current investigations are examining its broader applications in IL-12/IL-23-driven pathologies, potentially expanding its therapeutic scope.
Basic Information
Drug Type: Monoclonal antibody
Synonyms: Anti-interleukin-12 p40 monoclonal antibody; Stellara; Sterrara
Target: IL-12p40 x IL-23
Action: Inhibitors
Mechanism: IL-12p40 inhibitors(Interleukin-12 subunit beta inhibitors); IL-23 inhibitors(Interleukin-23 inhibitors)
Inactive Indication: Colitis, Microscopic; Dermatomyositis; Hand-Foot Syndrome
Originator Organization: Janssen Biotech, Inc.
Inactive Organization: Janssen-Cilag Ltd.; Xian-Janssen Pharmaceutical Ltd.; Centocor, Inc.
First Approval Date: European Union (15 Jan 2009)
Most Recent Events
| Date | Events |
| 23 JUL 2025 | AscellaHealth Service and Infrastructure Enhancements Support Specialty Drug Manufacturers to Protect Market Share Across Brand, Biosimilar and Generic Launches |
| 21 JUL 2025 | RedHill Receives Positive Feedback on Pathway to Approval of Groundbreaking RHB-204 for Crohn's Disease |
- Pipeline Status
Our Ustekinumab Biosimilar Pipeline Offers
Development Workflow of Ustekinumab Biosimilar Pipeline
| Early Development & Analytical Characterization | ||
| 1 | Project Initiation & Feasibility Assessment |
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| 2 | Cell Line Development |
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| 3 | Analytical Characterization & Comparability |
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| Non-Clinical Development | ||
| 4 | In Vitro Biological Activity Testing | Assess key functions such as IL-12/IL-23 binding, signal transduction inhibition, and cytokine modulation to establish biosimilarity with reference Ustekinumab. |
| 5 | In Vivo Pharmacology & Toxicology | Use appropriate animal models (e.g., humanized mice or primates) to evaluate pharmacokinetics (PK), immunogenicity, and systemic toxicity. Results inform formulation and dosage strategies. |
- Available Packages
Creative Biolabs provides adaptable and customizable service modules tailored to support every phase of your Ustekinumab biosimilar development journey—whether you're initiating analytical comparability studies or advancing toward regulatory submission. Select a service plan aligned with your current development needs or consult us for a fully personalized strategy.
| Items | classification | What we can offer |
| 1 | Recombinant Ustekinumab Biosimilar Antibody | We offer high-purity, functionally equivalent Ustekinumab biosimilar antibodies manufactured under optimized conditions, suitable for analytical testing, bioactivity assays, and preclinical research applications. |
| 2 | Stable Expression Cell Line | A well-characterized, high-expressing stable cell line for Ustekinumab biosimilar production is available, supported by detailed development records including clone screening, stability studies, and production scalability data. |
| 3 | Complete Analytical and Preclinical Data Package |
We provide a comprehensive data package featuring analytical comparability (e.g., structure, glycosylation, binding), biofunctional studies, pharmacokinetics, immunogenicity assessments, and non-clinical safety profiles—all aligned with global regulatory standards. Non-Clinical Data
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- Why Choose Us
End-to-End Development Expertise
From cell line generation to regulatory submission, our integrated service platform streamlines every phase of Ustekinumab biosimilar development. Clients benefit from reduced timelines, seamless coordination, and expert guidance throughout the project lifecycle.
Robust Technical Capabilities & Customization
We offer fully customizable service modules—including antibody production, analytical comparability, preclinical studies—tailored to meet specific regulatory and project requirements. Our proven track record ensures scientific rigor and regulatory alignment.
Regulatory-Ready Data & Global Support
Clients receive a comprehensive, submission-ready data package covering analytical and non-clinical domains. Our regulatory affairs team provides strategic consultation and dossier preparation to support EMA, or NMPA filings, helping accelerate product approval and market entry.
- Ready to Advance Your Ustekinumab Biosimilar Program
Get a custom development plan designed for your regulatory needs and timeline. Contact us today to request pricing, book a meeting, or download our brochure.
For research use only. Not intended for any clinical use.
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