Pfizer Fails To Make Its Mark In China-Focused Biosimilars Market
US-Based Firm Announces It Will Halt Biosimilar Development
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.
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After an earlier frenzy around local production and supply, policies to encourage generics, and fast-evolving procedural streamlining, Pfizer’s $350m ambition to develop and make cheaper biologics in China has come to an abrupt halt with the sale of its manufacturing site in a deal with services heavyweight WuXi Apptec.
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.
After receiving approval from the Chinese regulatory body for rituximab and trastuzumab, Shanghai Henlius Biotech has now received approval for its HLX03 adalimumab biosimilar rival to Humira. The company has partnered with Wanbang Biopharma for commercialization of HLX03 in China.