REGULATION FOR DEVELOPMENT OF BIOSIMILAR : A REVIEW
Journal Title: International Journal of Research and Development in Pharmacy & Life Sciences (IJRDPL) - Year 2016, Vol 5, Issue 6
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. Keywords: Biosimilars; Manufacturing; Stability; Efficacy; India Guidelines.
Authors and Affiliations
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, Gupta Surbhi| Clinical Research Department, Delhi Institute of Pharmaceutical Science and Research (DIPSAR), M. B. Road, Pushp Vihar, Sector - 3, New Delhi – 110017, Gulati Anshu| 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
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