healthCMI

Biosimilars are biopharmaceutical drug having active components, which are similar to one that has previously been licensed. They are identical copies of the original products and can be manufactured only when the patent for the original innovator product expires. Biologics or biosimilars are sensitive to changes in manufacturing process due to the higher molecular complexity. Biosimilars are generally derived from living cells of plants, animals, yeast, bacteria and viruses, through genetic engineering processes including controlled gene expression and recombinant DNA technology. In 2010, the Food and Drug Administration (FDA) approved biosimilars as a part of Patient Protection and Affordable Care Act. The approval process is based on thorough demonstration of similarity and comparability with existing approved product. Patent expiry of drugs and increasing government initiatives for biosimilars to drive growth of the biosimilars market Increasing dema...