FDA Begins Reviewing Henlius’ Trastuzumab

The Oncology Biosimilar Is Already Approved In China And The EU

The US FDA has accepted a BLA for Henlius’ trastuzumab biosimilar candidate HLX02, marking another step in the Chinese company’s push for the US oncology market

Immunohistochemistry image for HER2 shows positive cell membrane staining in this infiltrating ductal carcinoma.
Trastuzumab Treats HER2-2 Breast Cancers • Source: Shutterstock

The US Food and Drug Administration has accepted a biologics license application from Shanghai Henlius Biotech for its trastuzumab biosimilar candidate, codenamed HLX02.

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