Biosimilars: Novel Emerging Field of Biomedicine

Abstract


 A biosimilar is the new emerging drug product of the sector of Biologics that comes under speedily evolving area of pharmaceutical industry. It is the generic substitute for original research-based drugs. Since the Biologics are produced by a variety of products more commonly including cells extracted from humans, animals, microorganisms which varies phenotypically therefore they are “similar but not same” to the original product. Being a new product, it produces several challenges in the market including its regulation guidelines, production efficiency, quality management, and safety factors etc. The quality of these products along with its effectiveness and reduced costs are making them more and more popular. Different research is still being going on for enhancing the efficacy of biosimilars due to its more and more usage in the market. Several countries have developed their separate norms for the production and clinical usage of these biosimilars constituting Canada, Japan, Korea, and United States of America etc. The more biologics grab the attention of the eminent scientists for better innovations, the less marketing approval it gets. To enhance such a situation U S Congress passed the Biologics Price Competition and Innovation act 2009 and US FDA allowed “abbreviated pathway” for their approval and India being the most suited manufacturing area has also prepared certain guidelines stated as “Draft Guidelines on Similar Biologics” which were announced in June 2012, by Department of Biotechnology at Boston bio. The regulatory environment for biosimilars continues to evolve, both in recognition of advances in technology/ analytical methods and the availability of new targets for biosimilar development. With the advent of such efforts biosimilars are trying to surround the market. The demanding sector of biosimilars reveals the challenging gateway towards the nanomedicines also which shows that with the advancing biotechnology after these biosimilars, we are heading towards other newly biologically derived products.