A biosimilar is a biological medical product that is highly similar to an already approved “innovator” product. Unlike generics, which are identical copies of the approved product, biosimilars have small differences compared to the innovator product.
The first biosimilar was approved in the EU in 2006 and since then a wide range of biosimilars have reached market. The FDA and its European counterpart, the EMA, have released strict guidelines on the development of biosimilars. Somewhat surprisingly, the main goal of a biosimilar clinical development program is not to show safety and efficacy, but rather to demonstrate similarity to the innovator product in key areas, such as pharmacokinetics, pharmacodynamics and evaluation of efficacy, safety and immunogenicity in clinical studies.