Biosimilars are biological medicines which are similar to the existing and authorised biological medicines.also called follow on biologics they are derived from living organisms like bacteria yeast and made by r dna technology .they are produced after the expiry of data exclusivity of reference bio pharmaceuticals. They may contain simple molecules like erythropoietin or human insulin or complex products like monoclonal antibodies. They are not exact replicas of the reference biopharmaceuticals.thetefore scientific legal statutory aspects are debatable.they are complex molecules, any minutevariation in process of production can change the efficacy. Countries in europe, usa have made laws regarding the production of biosimilars.the licensing is base on totality of evidence which comprises chemical studies, non clinical applications etc.
