About this document

SFDA Guidelines on Biosimilar Quality by shivani hiremath is a document available to read on EtoBox.

This document provides guidelines on quality considerations for biosimilar products in Saudi Arabia. It outlines requirements for comparability exercises between a biosimilar and its reference medicinal product, including analytical methods to characterize physicochemical properties, biological activity, immunochemical properties, purity, and stability. Manufacturers must demonstrate biosimilarity in quality, safety and efficacy to the reference product based on sensitive analytical tools and a comprehensiv

Author

shivani hiremath

Language

EN