Blog Big Molecule Watch August 05, 2020

Celltrion’s Trastuzumab Biosimilar Earns WHO Prequalification Status

Celltrion recently announced that its trastuzumab biosimilar, Herzuma, has met the World Health Organization’s (WHO) prequalification standards.  WHO prequalification status is based on an assessment of the quality, safety, and efficacy of a medicine and enables the recipient to participate in UN procurement tenders.  Herzuma has been commercially available in Europe since May 2018, and in the United States since March 2020.  It is used to treat HER2-positive breast cancers and some gastric cancers.

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