Pharmacovigilance of Biosimilars

In lieu of an abstract, here is the article\u27s first paragraph: Biotech industry forms the backbone of the current pharmaceutical products. Seven out of top ten anticipated drugs of the industry in 2014 will be biologics [1]. Considering the fast pace growth of the biotechnological products, there is a parallel demand of biosimilars. As defined by FDA, “A biosimilar is a biological product that is highly similar to a U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product” [2]. Thus these biosimilar products become affordable alternatives to several biotechnological products, which are going off-patent. Along with the benefit of cost-effective therapy and scope of further research leading to the possibility of bio-superiors, biosimilars have led to formation of a whole new branch of biotech industry. However, there are various other concerns that require these biosimilars to be monitored closely