Stelara (Ustekinumab) Biosimilars

Stelara Biosimilars

Stelara (ustekinumab) is a fully human IgG1κ monoclonal antibody targeting interleukin 12 (IL-12) and interleukin 23 (IL-23). It is approved for the treatment of some diseases associated with chronic inflammation.

The development of Stelara biosimilars will allow more patients to access this powerful anti-inflammatory therapy, potentially leading to significant improvements in their quality of life. However, new biosimilars require comprehensive analysis to prove there are no clinically meaningful differences between the biosimilar and innovator products. Achieving regulatory approval relies on having robust and reliable characterization solutions that demonstrate comparability.

Our experience supporting biosimilar development has enabled us to design a suite of ready-to-use assays to analyze Stelera biosimilars, allowing you to uncover the important biological features of your product. With our integrated cell line development and cell banking services, we offer industry-leading support for all stages of your Stelara biosimilar project.


Simplify Your Biosimilar Characterization

Sartorius provides both custom analysis and a ready-to-use assay package for complete characterization of your Stelara biosimilar, from clone selection to submitting for regulatory approval. 

  • Uncover valuable insights into your biosimilar 

  • Accelerate development times 

  • Meet regulatory requirements 

  • Boost confidence in your product 

  • Limit the risks associated with biosimilar development 

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Stelara – Clinical Relevance

Stelara acts by interrupting aberrant cytokine signaling, which is a feature of many inflammatory diseases. Currently, Stelara has been granted regulatory approval to treat four autoimmune disorders: plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is usually offered as a treatment option when other therapies have been ineffective or poorly tolerated. 

Stelara acts as an immunosuppressant. It moderates the immune response and reduces inflammation, leading to an improvement of the associated symptoms. 

Stelara – Mechanism of Action 

Stelara inhibits the inflammatory cytokines IL-12 and IL-23.  The Fab domain of Stelara binds to the p40 subunit of IL-12 and IL-23, blocking their interaction with the  IL-12Rβ1 receptor.  

When IL-12 and IL-23 bind their receptor, they trigger its activation, which begins a signaling cascade resulting in the production of T helper cytokines, Th1 and Th17. These pathways lead to the differentiation and activation of T cells, which contribute to inflammation. 

Constitutive upregulation of cytokine signaling has significant implications in the molecular basis of autoimmune diseases 

Thus, by disrupting IL-12 and IL-23 signaling, Stelara inhibits the molecular pathways contributing to the chronic inflammation observed in these diseases. 

Stelara – Biosimilar Characterization 

We offer a comprehensive range of integrated services to support the biological, physicochemical, and structural evaluation of your Stelara biosimilars, including complete characterization and comparability testing.   

  • Physicochemical and structural assays reveal detailed insights into the composition of your biosimilar  

  • Binding assays allow you to quantify and evaluate the binding of your Stelara biosimilar to its target molecule (IL-12 and IL-23) as well as other components of the immune system. 

  • Our functional assay measures the potency of your Stelara biosimilar against IL-12 and IL-23 in a cell-based platform. 

We also offer cell line development services using our CellcaCHO cell and optimized media. 

Assay Types

Physicochemical and structural characterization is a crucial step in determining the potential biological activity, stability, and safety of your biosimilar.  

Our versatile platform of physicochemical methods provides the basis for your comparability study.  With options suited for clone selection through to formal comparability, we can build detailed insights into the properties of your biosimilar.   

The combination of our off-the-shelf physicochemical and structural analyses and our binding and bioassays allows you to evaluate the structure-function relationship and ticks the regulators' box for orthogonal comparability.   

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Bioassays provide the means to directly assess the fundamental biological activity of Stelara biosimilars. As such, they represent a vital component of a product characterization study.   

Our Stelara IL-12 Neutralization Bioassay is a cell-based assay qualified to measure the neutralization activity of Stelara biosimilar products for use in clone selection, process development, and similarity studies.  The ability of your biosimilar to inhibit IL-12 and IL-23 is reported relative to a reference standard, helping you to evaluate the potency of your biosimilar. 

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Interaction studies are fundamental to understanding the function of monoclonal antibodies as therapeutic molecules.  

Our binding assays can be developed using different platforms, including ELISA, electrochemiluminescence (MSD), and Surface Plasmon Resonance (SPR). They can also be performed with various reporting systems to provide you with the comprehensive, industry-leading comparability reports required to understand all aspects of the performance of your Stelara molecule. Our platforms include IL-12, IL-12p70, 12-p40, IL-12p80 and IL-23 binding assays.  

Our platform Fc binding methods can be quickly qualified for use with Stelara.  We can assess the full range of Fc receptors can using sensitive label-free SPR technology. 

  • Fc-Gamma Receptor I (FcRI)  

  • Fc-Gamma Receptor IIa (both R and H variants) (FcRIIa)  

  • Fc-Gamma Receptor IIb (FcRIIb)  

  • Fc-Gamma Receptor IIIa (V) (FcRIIIa V)  

  • Fc-Gamma Receptor IIIa (F) (FcRIIIa F)  

  • Fc-Gamma Receptor IIIb (FcRIIIb) 

  • Fc-Gamma Neonatal Receptor (FcRn) 

We also provide a Stelara C1q binding assay to determine the capability for complement-dependent cytotoxicity. 

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