China Lays Out Requirements For Biosimilar Extrapolation
Two More COVID Vaccines Also Approved
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.
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Pfizer threw in the towel for biosimilar development in China last week, just three years after opening its $350m Global Biotechnology Center, based in the Hangzhou Economic Development Area.
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.
China's historic antitrust fine against Alibaba indicates regulatory attention to anticompetitive practices is mounting. Past cases show the pharma sector is not immune and while it remains segmented, investigators appear to be taking a generally more sophisticated approach to transgressions.