The guidance defines: 1) Levels of change 2) Recommended chemistry, manufacturing, and controls tests for each level of change 3) In-vitro dissolution tests and/or in vivo bioequivalence tests for each level of change
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 optimization, 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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