Bioanalysis >> Biosimilars >> Adalimumab Assays

Adalimumab Biosimilar Assays

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A diverse set of methods to evaluate comparability of both the biosimilar drug and it's clinical performance

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Adalimumab (Humira®) is a humanized recombinant human IgG1 monoclonal antibody specific for tumor necrosis factor-alpha (TNF-α) that has been clinically applied for treatment of rheumatoid arthritis (RA), psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, chronic psoriasis, Crohn's disease, and ulcerative colitis.

Adalimumab mean steady-state trough concentrations of approximately 5 μg/mL to 12 μg/mL were observed at doses of 40 mg, 80 mg, and 160 mg of adalimumab.  Among adalimumab monotherapy recipients, 3-26% had reported development of antibodies to adalimumab.

Evaluation of the comparability of adalimumab biosimilars to the innovator drug should follow the guidelines laid out by the FDA and EMA. The analysis should be multifactorial, taking into account both the physicochemical characteristics and clinical performance of the biosimilar compared to the innovator. Eurofins Bioanalytical Services offers an off-the-shelf ADA  assay for comparability testing of biosimilar adalimumab.

Clinical Assays

PK assay

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Adalimumab ADA

  

Adalimumab ADA 

Representative curve for sensitivity of anti-adalimumab antibody in human serum

  

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