Background

Generic drugs account for more than 90% of the marketed drugs in China. In 2012, China initiated the equivalence evaluation plan to require that generics should be equivalent to originator drugs in quality and efficacy. In 2016, China started implementing equivalence evaluation requirements for chemical drugs’ oral solid dosage forms. In 2020, the evaluations expanded to chemical injections.

Quality and therapeutic equivalence evaluations push pharmaceutical companies to develop and produce generic drugs of higher quality. If the generics with high levels of quality and efficacy pass equivalence evaluations, they will be deemed clinical substitutes for originator drugs. With lower prices, the generics have more advantages than originator drugs in public medical institutions’ volume-based procurements. Thus, generics grow to take higher market shares.

This webinar aims to help pharmaceutical companies understand China’s regulatory requirements for the quality and therapeutic equivalence evaluation, its market impacts, and the data on accepted and approved applications for equivalence evaluations.

Contents

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