Humira (Adalimumab) Biosimilars

Humira Biosimilars

Humira (adalimumab) is a fully-human monoclonal antibody belonging to a class of pharmaceuticals called anti-TNFs (anti-tumor necrosis factors). TNFs are present at high levels in conditions associated with chronic inflammation, and Humira is approved to treat a variety of these illnesses.

Humira is a popular target for biosimilar developers. The manufacture of Humira biosimilars can help expand the reach of this powerful drug through improved affordability. However, Humira possesses a wide range of distinct biological activities, requiring extensive comparability to comply with regulatory guidelines.

Sartorius has extensive experience in characterizing these activities, having supported the development of over 20 Humira biosimilars, including some that are now approved. Our industry-leading expertise has allowed us to develop pre-qualified, integrated characterization and comparability packages to assist the development and production of Humira biosimilars.

Simplify Your Biosimilar Characterization

Sartorius offers a comprehensive panel of off-the-shelf assays supporting the characterization of your Humira biosimilar. 

  • 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 Humira

Humira targets tumor necrosis factor-alpha (TNFα), which is a potent proinflammatory cytokine. TNFα is thought to have a critical role in the development of chronic inflammatory conditions, making it an excellent target for therapeutics. 

Humira is considered the most successful biologic of the early 21st century and has been approved to treat various autoimmune disorders, usually in cases where other treatments have failed. These diseases include severe rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis, amongst other chronic and debilitating conditions. 

TNFα is considered the "master regulator" of proinflammatory cytokine production, representing an appealing target for anti-inflammatory therapies. It exists in both soluble and membrane-bound (mTNFα) forms, and is primarily released by macrophages in response to trauma or infection. TNFα initiates a wide range of downstream effects and acts by binding to two cell surface receptors – TNFR1 and TNFR2 – which trigger intracellular signaling leading to inflammation.  

Humira disrupts the cycle of chronic inflammation by helping to suppress the immune system. It operates through several mechanisms but primarily exerts its actions by binding and neutralizing soluble TNFα and preventing the activation of TNFRs, blocking inflammation signals.  

As well as this targeted effect on signaling, Humira also mediates a range of additional immune responses, including complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC).

Developing a successful biosimilar starts with your cell line. Our comprehensive range of ready to use testing solutions for Humira are compatible with our CellcaCHO cell line development and optimized media. We support a seamless transition from cell line development into our cGMP cell banking and characterization services, accelerating your program towards your first GMP batch. 

Sartorius offers a comprehensive range of integrated services to support the analysis of your Humira biosimilars. Our off-the-shelf assays are purpose developed for comparability studies to aid the approval process. 

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

  • Our binding assays evaluate the binding of your Humira biosimilar to TNFα, as well as key mediators of the immune response 

  • Our functional assays measure the biological activity of your Humira biosimilar against TNFα and other immune pathways 

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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We have developed a range of off-the-shelf bioassays to support Humira biosimilar process development, characterization, and comparability studies.  

Humira has many mechanisms of action; therefore, a range of bioassays are required to fully characterize the product and demonstrate comparability with the innovator material. Principally, Humira exerts its function by binding and neutralizing circulating TNFα. Sartorius currently provides six versions of the Humira TNFα neutralization assay offering the following features: 

  • Measurement of cell death/viability using L929 cells 

  • Measurement of cell death/viability using U937 cells 

  • Measurement of apoptosis using U937 cells 

  • Measurement of ELAM-1 expression (a marker of cell adhesion) using HUVEC cells 

  • Measurement of ICAM-1 expression (a marker of cell adhesion) using HUVEC cells  

  • Measurement of VCAM-1 (a marker of cell adhesion) using HUVEC cells. 

Sartorius also delivers complete ADCC and CDC testing solutions for Humira using our off-the-shelf methods. Our proprietary cell line expresses mTNFα at sufficiently high levels to measure ADCC and CDC mediated by all tested TNFα targeting antibody-based therapeutics.  

If you require a Humira bioassay method that is not listed, please contact us. 

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TNFα binding represents one of the critical quality attributes of your Humira biosimilar. Our TNFα binding assays can be performed using a wide variety of different platforms and designs.  

  • Humira TNF-Alpha Binding ELISA by Electrochemiluminescence (MSD) - This assay can be performed using recombinant TNFα or cells engineered to express mTNFα. It reports the relative binding of biosimilar and innovator Humira material as a percentage of a designated reference lot, with comprehensive parallelism assessments. We can also adapt this method for performance as a traditional ELISA platform where required. 

Fc Binding Assays 

Fc characterization forms a critical part of Humira comparability studies.  We perform our Fc-gamma receptor assays using SPR instruments, which are versatile, label-free systems providing exceptional sensitivity. The following assays are available: 

  • Humira Fc-gamma Receptor I (FcRI)  

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

  • Humira Fc-gamma Receptor IIb (FcRIIb)  

  • Humira Fc-gamma Receptor IIIa (V) (FcRIIIa V)  

  • Humira Fc-gamma Receptor IIIa (F) (FcRIIIa F)  

  • Humira Fc-gamma Receptor IIIb (FcRIIIb)  

An important factor in the efficacy of therapeutic antibodies is the serum half-life, which is largely determined by the interaction between the antibody and the neonatal Fc receptor (FcRn). Therefore, FcRn binding is crucial to demonstrate comparability between Humira biosimilar and innovator.  Sartorius provides off the shelf Humira FcRn binding assays by SPR. 

The Fc region is also responsible for Humira's CDC effector function through binding C1q and activating the classical complement pathway.  Sartorius offers C1q binding assays by both ELISA and SPR. 

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