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The first Avastin(Bevacizumab) Biosimilar approval in China granted by NMPA

Classification:
Company news
Author:
QILU PHARMACEUTICAL
Source:
QILU PHARMACEUTICAL
Release time:
2019/12/09 16:45
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[Abstract]:

The National Medical Products Administration today approved Qilu’s Ankeda as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Ankeda is the first Avastin biosimilar approved in China for the treatment of cancer.

The NMPA’s approval of Ankeda is based on review of evidence that includes extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Ankeda is biosimilar to Avastin.

Qilu made big investment on Ankeda development. It took less than 1.5 years for the NMPA to greenlight Qilu’s Ankeda. Qilu is committed to bringing more biosimilars to patients to help lower healthcare costs and increase access to important therapies.

 

 

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