Regulations for the development of biosimilar
Journal Title: World Journal of Pharmaceutical Sciences - Year 2016, Vol 4, Issue 11
Abstract
Present article signifies the exigency for robust regulation involved in the development of biosimilars. The principle for the 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 the development of biosimilars.
Authors and Affiliations
Surbhi Gupta
Keywords
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