Regulations for the development of biosimilar

Author : Surbhi Gupta, S.K Gupta

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.

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