Regulatory imperatives in chemistry, manufacturing, and control for biosimilars


The Asia-Pacific (APAC) region has emerged as a dynamic centre for the development and approval of biosimilars, revealing a complex regulatory landscape that requires meticulous attention to chemistry, manufacturing, and controls (CMC) factors. This article explores the essential regulatory aspects inherent to CMC for biosimilar assessment and approval by agencies across APAC countries. It also focuses on biosimilar guidance from regulatory agencies and how this can be interpreted by sponsors when performing clinical trials and registration of biosimilars.

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