FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

China Approves Its First Biosimilar

March 6, 2019
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China’s National Medical Products Administration has given the green light for Hanlikon, a biosimilar version of Genentech’s Rituxan (rituximab) in injection form.

Approved by the FDA in 1997, Rituxan is the first monoclonal antibody used to treat cancer and is indicated for treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and certain autoimmune diseases.

China’s first biosimilar was developed by Shanghai Fuhong Hanlin Bio-Pharmaceutical, a subsidiary of Shijiazhuang No. 4 Pharmaceutical Group.

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