What is Exemptia?
Exemptia journey- Data on Biosimilarity
Exemptia contains adalimumab which is biosimilar of originator’s adalimumab. It is an exact fingerprint match of originator’s adalimumab. Biosimilars are defined as ‘similar’ or ‘highly similar’ to the reference medicinal products (originator products) following the EMA (European Medicines Agency) and FDA (Food and Drug Administration, USA) regulatory guidelines. Biosimilars having the similar level of efficacy and safety compared to that of the originator products provide additional advantage to patients in terms of affordability and lost-cost of therapy, while expanding the patient access to therapies. Despite of its complex molecular nature, a target-directed approach for development has been proven highly successful to generate monoclonal antibodies similar to the originator products at the level of individual quality attributes with same functional properties.
EXEMPTIA, termed as ZRC-3197, has been developed indigenously by Zydus-Cadila (Cadila Healthcare Ltd.), as biosimilar medicinal product of originator HUMIRA®. Originator HUMIRA®, a TNF blocker, is used for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and plaque psoriasis. Adalimumab, which serves the active substance of originator HUMIRA® is a fully human monoclonal IgG1 antibody produced recombinantly in genetically engineered Chinese Hamster Ovary (CHO) cells. Adalimumab is composed of 1330 amino acids with a molecular weight of about 148 kDa. Physicochemical and functional characterization of EXEMPTIA and HUMIRA®, on a comparative basis to demonstrates biosimilarity between both.
Comparison between the EXEMPTIA and originator HUMIRA® by HP-SEC analysis
Comparative analysis of EXEMPTIA and originator HUMIRA® for different size variants of adalimumab
Charge heterogeneity profile comparison between the EXEMPTIA and HUMIRA
Glycans profile comparison between the EXEMPTIA and HUMIRA
Secondary structure analysis