China Lays Out Requirements For Biosimilar Extrapolation
Two More COVID Vaccines Also Approved
Executive Summary
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.
You may also be interested in...
Pfizer Fails To Make Its Mark In China-Focused Biosimilars Market
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.
Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity
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.
Medtechs Must Reflect On China Localization Policies As VBP Expands
China continues to roll out volume-based procurement for medical devices and pharma products and companies should plan their strategies accordingly, advises EY Parthenon’s Hua Su.