REGULATION FOR DEVELOPMENT OF BIOSIMILAR : A REVIEW

Authors

  • Chauhan K Meenakshi NDDS Research Lab, Department of Pharmaceutics, Delhi Institute of Pharmaceutical Science and Research (DIPSAR), M. B. Road, Pushp Vihar, Sector - 3, New Delhi – 110017
  • Gupta S K Clinical Research Department, Delhi Institute of Pharmaceutical Science and Research (DIPSAR), M. B. Road, Pushp Vihar, Sector - 3, New Delhi – 110017
  • Surbhi Gupta Clinical Research Department, Delhi Institute of Pharmaceutical Science and Research (DIPSAR), M. B. Road, Pushp Vihar, Sector - 3, New Delhi – 110017
  • Anshu Gulati NDDS Research Lab, Department of Pharmaceutics, Delhi Institute of Pharmaceutical Science and Research (DIPSAR), M. B. Road, Pushp Vihar, Sector - 3, New Delhi – 110017

Keywords:

Biosimilars; Manufacturing; Stability; Efficacy; India Guidelines

Abstract

Present article signifies the exigency for regulation and regulatory bodies involved in development of biosimilars. The principle for development of biosimilars included opting adequate reference product, manufacturing process optimisation, quality control procedure, preclinical and clinical studies. India’s first guidelines were enforced in 2012, with amendments in 2016. Thus, we elaborated the amended guidelines for development of biosimilars.

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Published

2016-11-15

How to Cite

Meenakshi, C. K. ., Gupta S K, Gupta , S., & Gulati , A. (2016). REGULATION FOR DEVELOPMENT OF BIOSIMILAR : A REVIEW. International Journal of Research and Development in Pharmacy & Life Sciences, 5(6), 2362-2368. Retrieved from https://ijrdpl.com/index.php/ijrdpl/article/view/181