Biosimilars – an overview

Abstract

Biosimilars are a new class of drugs intended to offer comparable safety and efficacy to the reference. Biologic products are being developed over the past three decades. The expiry of patent protection for many biological medicines has led to the development of biosimilars in UK. Biosimilar or similar biologic use has increased in the recent years following the approval of the first biosimilar in early 2000. India is one of the leading manufacturers of similar biologics. India has developed a new guideline in 2012 for the pre- and post-marketing approval of similar biologics. The overall risk is modest with Biosimilars, but regulatory pathways are required because of structural complexity, manufacturing process and risk for immunogenicity. In the last few years, India has seen a robust development in its biosimilar portfolio. The Indian biosimilar market is composed for big growth, by the launch of new products and growing acceptance of biosimilar. India’s top manufacturers are also entering the biosimilars market, with more than 50 biosimilar products approved by the Central Drugs Standard Control Organization (CDSCO). This review shows the evolution of biosimilar development regarding regulatory, manufacturing bioprocess, comparability, and marketing.