A REVOLUTIONARY GENERICS (BIOSIMILARS)

Abstract

Biosimilar , or similar biological medicinal products, are used to describe officially approved new versions or generic version of innovative patented biologically active pharmaceutical products referring to existing ones which have been submitted to regulatory authorities for marketing authorization by an independent applicant after the time of protection of the data has expired for the original products. In other words they are "small-molecule" biological drugs,which generally exhibit high molecular complexity, are quite sensitive to manufacturing process and other changes made during their development from original patented drug molecule, e.g. the patent of the first approved recombinant drugs e.g. insulin, human growth hormone, interferons, erythropoietin etc. The terms biogeneric, second entry biological, subsequent entry biological, non-patented biological product and multisource product have also been used for these substances but the EMEA (European Agency for the Evaluation of Medicinal Products) prefers the term biosimilar (the FDA coined the term “follow-on biologicâ€). Biopharmaceuticals are proteins with considerable therapeutic and structural diversity. They tend to be between 100 and 1000 times larger than traditional small molecule drugs