Opdivo® (Nivolumab) Biosimilars

Opdivo® Biosimilars

Opdivo® (Nivolumab) Is a Human IgG4 Monoclonal Antibody That Targets Programmed Cell Death Protein 1 (PD-1)

Opdivo® belongs to a class of anti-cancer drugs called immune checkpoint inhibitors. Immune checkpoint inhibitors block signaling pathways that enable tumors to evade immunosurveillance, promoting the immune-mediated destruction of cancer cells. These drugs were initially applied in the treatment of melanoma but are now more widely used in cancer therapy.

The effectiveness and increased uptake of Opdivo® have sparked interest in the development of biosimilars, which will provide more cost-effective and widely accessible treatments. However, manufacturers must carry out comprehensive analyses of their drugs to meet the requirements for biosimilar approval, a process that can be complex and time-consuming.

Sartorius offers a suite of ready-to-use assays to comprehensively characterize your Opdivo® biosimilar. Our solutions include binding assays, bioassays, and physicochemical and structural characterization, designed to accelerate your development process and meet regulatory requirements.

Our nivolumab assays are also suitable for other molecules which target PD-1 such as pembrolizumab (Keytruda®) and cemiplimab (Libtayo®) and can also be adapted easily to molecules that target PD-L1 such as atezolimumab (Tecentriq®), durvalumab (Imfinzi®), and avelumab (Bavencio®).

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Simplify Your Biosimilar Characterization

Sartorius provides both custom analysis and a ready-to-use assay package for complete characterization of your Opdivo® 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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Characteristics of Opdivo®

Opdivo® acts by interfering with PD-1 signaling, which normally acts as an immune checkpoint. Immune checkpoints help refine the activity of the immune system and prevent it from targeting and attacking healthy human cells.  

Immune checkpoints can help prevent autoimmunity but also present an opportunity for cancer cells to evade immune detection and destruction by stimulating immune checkpoint signaling.  

Cancer cells often overexpress proteins involved in PD-1 signaling pathways, a feature associated with a poor prognosis. Therefore, immune checkpoint inhibitors – like Opdivo® – which boost the immune system's action against cancer cells, are an important class of cancer therapies.  

Opdivo® is currently approved for the treatment of many advanced cancers, including lung, liver, kidney, and bladder cancer.

Opdivo® exerts its anti-cancer effects by binding PD-1, an inhibitory receptor found on the surface of T and B cells. PD-1 has two endogenous ligands -PD-L1 and PD-L2 - located on the surface of many cell types, including immune cells, epithelial cells, and cancer cells.   

The interaction of PD-1 with PD-L1 and PD-L2 stimulates a signaling cascade which downregulates the immune response by inhibiting T cell activation. Cancer cells often overexpress PD-1 or PD-L1/2, boosting the inhibitory signaling pathway and protecting the tumor from the immune system. 

Opdivo® blocks PD-1, preventing PD-L1 and PD-L2 from binding and initiating their immunosuppressive actions. This action better equips the immune system to target and kill cancer cells.

Our analytical packages support you through all biosimilar development stages, helping you build a complete picture of your 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 Opdivo® biosimilar to PD-1 as well as other components of the immune system to cause unwanted activation.  

  • Our functional assays measure the biological activity of your Opdivo® biosimilar in both cell-based and ELISA platforms.  

These assays are also adaptable for the characterization of pembrolizumab (Keytruda®) biosimilars. 

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 Opdivo® biosimilars. As such, they represent a significant component of a product characterization study.   

Our extensive experience in developing novel bioassays to assess a wide range of monoclonal antibodies has enabled us to create both immunoassay (potency ELISA) and cell-based (reporter assay) platforms to measure the blocking activity of Opdivo® biosimilars. These assays are applicable to clone selection, process development, characterization, and similarity studies.  

As an IgG4 molecule, Opdivo® should not induce antibody-dependent cell-mediated cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC). However, regulators require studies which demonstrate a lack of function comparable to the innovator product. While it is often challenging to prove a negative, Sartorius has developed a robust approach to report a negative result with appropriate levels of confidence using our off-the-shelf lack of function assay, which has been verified as acceptable to regulatory authorities.   

If you require an Opdivo® bioassay method that is not listed, please contact us.


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Sartorius has developed Opdivo® PD-1 binding assays to support process development through characterization and comparability studies of your biosimilar. These packages are also applicable to pembrolizumab (Keytruda®) biosimilar testing. 

Our ELISA and SPR methods provide consistent and complementary reports of the relative binding of your biosimilar compared to a reference lot. 

Our Fc binding platforms allow you to determine potential immune interactions. We can assess the full range of Fc gamma receptors using sensitive label-free SPR technology, to determine potential Fc function: 

  • 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. C1q is the first mediator of the classical complement system, and thus helps to determine the capability for complement-dependent cytotoxicity. 

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Related Assets

Application Note: SPR Assays to the Assess Similarity Between Innovator and Biosimilar Versions of Nivolumab (Opdivo®)

PDF | 720.0 KB

Application Note: Capillary Isoelectric Focusing (cIEF)

PDF | 701.5 KB

Application Note: Immuno-Oncology In Vitro Assays

PDF | 451.9 KB

Poster: Development and Qualification of a Complex Potency ELISA

PDF | 1.5 MB

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