Stability Protocol Design for Biosimilar Comparability
Stability Protocol Design for Biosimilar Comparability How to Design Stability Testing Protocols for Biosimilar Comparability Assessments Biosimilars are not generic copies of biologics; rather, they are highly similar versions of approved reference products with no clinically meaningful differences in terms of safety, purity, or potency. Demonstrating stability comparability is a cornerstone of biosimilar development. This…
Read More “Stability Protocol Design for Biosimilar Comparability” »