General considerations of quality study for biosimilar products containing recombinant monoclonal antibodies / 中国药学杂志

ABSTRACT

OBJECTIVE: Different from new drug application, research on biosimilar products mainly focuses on similarity in quality as well as equivalence or non-inferiority in clinical application compared to reference products. Quality research on biosimilar products is one of the most important research fields, for not only it is the main work to secure the safety, efficacy and quality of the products, but also it is the key point that would determine whether the products could follow the requirements for development of biosimilar products.