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Chinese Trastuzumab Biosimilar Demonstrates Equivalency in HER2+ Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Monday, Nov 25, 2019

Binghe Xu, MD, PhD, of the Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences in Beijing, China

Binghe Xu, MD, PhD

The Chinese-manufactured trastuzumab (Herceptin) biosimilar HLX02 demonstrated similar objective response rates (ORRs) to the reference product at 24 weeks in patients with treatment-naïve or recurrent metastatic HER2-positive breast cancer, according to results of a phase III trial (NCT03084237) that were presented at the 2019 ESMO Asia Congress.1,2

“The development of biosimilars is important both for patients, by improving access to cancer drugs, and for health systems, allowing cost savings that can be reinvested in patient care and support the sustainability of healthcare systems,” Giuliani said. “Biosimilars are safe and effective drugs which can finally allow those patients to receive an appropriate standard of care.”


  1. Xu B, Zhang Q, Sun T, et al. First China-manufactured trastuzumab biosimilar HLX02 global phase III trial met primary endpoint in breast cancer. Presented at: ESMO Asia Congress 2019; November 22-24, 2019; Singapore. Abstract LBA6.
  2. First China-manufactured Trastuzumab Biosimilar HLX02 Global Phase III Trial Met Primary Endpoint in Breast Cancer. European Society for Medical Oncology. Published November 22, 2019. Accessed November 22, 2019.
  3. Zhang Q, Xu B, Zhang Q, et al. Global clinical trials validating bioequivalence with China-manufactured trastuzumab biosimilar, HLX02, and Herceptin. Ann Oncol. 2018;29(suppl_9):ix13-ix20. doi: 10.1093/annonc/mdy428.

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