ABSTRACT
A biosimilar drug is an identical version of an existing molecule that was originally derived from a virus, blood, toxin, vaccine, protein, blood component, therapeutic serum, or derivative, allergenic product, antitoxin, or analogous product. Biosimilar drugs are becoming increasingly popular. It is essential, in order to guarantee both the efficacy and the safety of the drug, that the biosimilar be identical to the product that has already been approved. The price of a biosimilar is reasonable, and it reduces overall health care spending. Analytical validation, structural similarity, and safety are the primary concerns for regulatory approval, which is far easier to obtain than permission for original biologicals.
