Simponi Biosimilars
Simponi (golimumab) is a fully human IgG1 monoclonal antibody. Like Humira, Remicade, and Enbrel, Simponi targets TNFα, a master regulator of the inflammatory response. Simponi is used in the treatment of several autoimmune conditions in which inflammation is an important driver of the disease.
Simponi biosimilars allow more patients to benefit from access to high quality and affordable therapies. To achieve regulatory approval, Simponi biosimilars must undergo extensive analysis to demonstrate biosimilarity to the innovator project, a process that can be technically challenging and time-consuming.
At Sartorius, we have supported the development of over 25 anti-TNF biosimilars. Our ready-to-use, integrated characterization and comparability packages are designed to support Simponi biosimilar development and help you advance towards your first GMP batch.
Sartorius offers a panel of ready-to-use assays for the comprehensive characterization of your Simponi biosimilars.
Uncover valuable insights into your biosimilar
Accelerate development times
Meet regulatory requirements
Boost confidence in your product
Limit the risks associated with biosimilar development
Simponi – Clinical Relevance
Simponi targets TNFα, a pro-inflammatory cytokine implicated in a variety of autoimmune and inflammatory conditions. Simponi is an approved therapy for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
Normally, TNFα is released by macrophages in response to infection. It can then trigger a complex network of signaling pathways, ultimately leading to the recruitment of immune effectors and inflammation.
Excessive TNFα signaling can lead to chronic inflammation. By blocking TNFα, Simponi helps regulate the activity of the immune system, reducing the inflammatory state and alleviating the symptoms of these diseases.
Simponi – Mechanism of Action
The Fab-region of Simponi allows the antibody to form stable complexes with both soluble and membrane-bound TNFα. This interaction prevents TNFα from interacting with and activating its receptors (TNFRs), effectively neutralizing the activity of TNFα.
TNFα is a small signaling protein involved in a vast and heterogeneous array of different signaling pathways, including the induction of nuclear factor kappa B (NF-κB), mitogen-activated protein kinase (MAPK) signaling, and apoptosis.
Through binding to TNFα, Simponi can neutralize the wide range of different biological activities that are mediated by TNF-α.
Simponi – Biosimilar Characterization
Our analytical packages support you through all biosimilar development stages, helping you build a complete picture of your Simponi biosimilar through orthogonal methods.
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 Simponi biosimilar to TNFα as well as other immune system components
Our functional assays measure the biological activity of your biosimilar, including TNFα neutralization capabilities as well as its ability to activate immune responses.
Our bioanalytical comparability services are complemented by a suite of biosafety methods which can be used to release your batches of biosimilar drug.
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.
As with the majority of therapeutic monoclonal antibodies, Simponi has a number of different mechanisms of action, and a range of bioassays are required to characterize the product and demonstrate comparability with innovator material.
Simponi L929 Neutralization Assay
We have fully qualified our neutralization assay using L929 cells as the primary potency assay for Simponi biosimilars. This allows us to determine the ability of your biosimilar to inhibit TNFα function, reported as a relative potency measurement against the reference standard.
CDC and ADCC Bioassays
The potential for TNFα to be membrane-bound requires full characterization of the Fc effector functions of Simponi. Complement-dependent cytotoxicity (CDC) and antibody-dependent cytotoxicity (ADCC) bioassays measure the combined activity of the Fab binding and effector functions of Simponi, mediated through an initial interaction with C1q (CDC) or the Fc-Gamma Receptor IIIa (FcRIIIa) (ADCC).
Our CDC assays can be performed with complement from human or rabbit serum, providing a robust assessment. Our classical ADCC assays are performed using effector cells from genotyped donors.
We offer Simponi TNFα binding assays using an upgraded version of the traditional ELISA on the Mesoscale Discovery (MSD) platform to report the relative binding of biosimilar and innovator Simponi material, with comprehensive parallelism assessments.
Our Fc binding methods can be quickly qualified for use with Simponi. The full range of Fc gamma receptors can be assessed 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)
Additionally, we offer off-the-shelf assays for the neonatal Fc receptor (FcRn) - using SPR - and C1q - using ELISA or SPR - to complete our comprehensive Fc comparability package.
