amolmali

Biosimilar monoclonal antibodies can be defined as biological molecules derived from living cells or organisms. These are large complex molecules. Biosimilars are developed after the expiry of patent of approved recombinant drugs, and are also known as biologics. These biologics display a certain level of variability which can be attributed to the variations in the biological expression system of the recombinant and the manufacturing process. Biosimilars are regulated by the various governing bodies in different countries. In the U.S., the FDA regulates the release of these biosimilars, which are required to undergo pharmacovigilance regulations as its reference approved monoclonal antibody. In Europe, biosimilars are approved by the European Medicines Agency (EMEA). Manufacturers of biosimilars are required to submit risk management plan in addition to the marketing application. Increase in patent expiries of blockbuster monoclonal antibodies has led to a rise in interest among phar...