Biosimilars are biological products that are ‘similar’ or ‘highly similar’ to the reference medicinal products (originator products) following the EMA (European Medicines Agency), FDA (Food and Drug Administration, USA) and the CDSCO regulatory guidelines. Biosimilars have similar level of efficacy and safety compared to that of the originator products and provide additional advantage to patients in terms of affordability and accessibility.
Adalimumab Biosimilar, trade name Exemptia, is a TNF inhibiting anti-inflammatory drug manufactured by Zydus Group. Exemptia, developed by the researchers at the Zydus Research Centre contains Adalimumab as an active ingredient. On Dec 9, 2014 Zydus Group became the first company in the world to launch a biosimilar version of Adalimumab.
Zydus Group becomes the first company anywhere in the world to launch the biosimilar of Adalimumab – the world’s largest selling therapy. This novel non-infringing process for Adalimumab Biosimilar and a novel non-infringing formulation have been researched, developed and produced by scientists at the Zydus Research Centre. The biosimilar is the first to be launched by any company in the world and is a ‘fingerprint match’ with the originator in terms of safety, purity and potency of the product.
Adalimumab Biosimilar is a fully human monoclonal IgG1 antibody produced recombinantly by Chinese Hamster Ovary (CHO) cells. Adalimumab Biosimilar consists of 1330 amino acids containing glycoprotein which has two copies of heavy and two copies of light chains in heterodimeric form with a molecular weight of 148 kDa (approx.)
Adalimumab binds specifically to Tumor Necrosis Factor-alpha (TNF-α) and blocks its interaction with the p55 and p75 cell surface TNF receptors. This effectively blocks the TNF mediated inflammation messenger from recruiting the inflammatory cells.
Adalimumab which serves the active substance of Exemptia is a fully human monoclonal IgG1 antibody produced recombinantly in genetically engineered CHO cells. Adalimumab is composed of 1330 amino acids with a molecular weight of about 148 kDa.