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China Lays Out Requirements For Biosimilar Extrapolation

Two More COVID Vaccines Also Approved

 
• By Brian Yang

In what could be a blow to some aspiring developers eyeing the nascent but growing biosimilars market in China, new rules lay out when extrapolation of approved indications of reference biologics will be allowed, meaning this will not be automatic.

biosimilar_syringe
CHINA OUTLINES BIOSIMILAR EXTRAPOLATION RULES, APPROVES TWO MORE COVID VACCINES • Source: Shutterstock

The latest regulation on biosimilars in China lays out more clearly the circumstances under which developers of such products would have to apply and get approval for specific indications, a situation that might apply to some of the world’s biggest-selling biologics available in the country as these come under increasing biosimilar pressure.

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