Biosimilar and it’s Current Perspective – A Review

Abstract

Biosimilars are biological products that are the replicas of their innovator biopharmaceuticals. The term “biosimilar” is in common use in the European Union, while the term “follow on biologics” is more popular in the American context. These are developed after patent expiration of innovator biopharmaceuticals and are submitted for separate marketing approval. In view of the structural and manufacturing complexities of biopharmaceuticals, biosimilars should not be considered as “biological generics”. These are rather unique molecules with limited data at time of approval, so there are concerns about the safety and efficacy of biosimilars. The Indian biotechnology industry is also gaining momentum, with revenues of over U.S. $ 2.0 billion in 2006, 70% of which is biopharmaceuticals. These are projected to reach up to $580 million in 2012.This article will address the differences between biosimilars and chemical generics, issues of concern with the use of biosimilars and need of appropriate regulations for their approval.