FDA Approves Trastuzumab Biosimilar for the Treatment of HER2-Overexpressing Breast and Gastric Cancers

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Shanghai Henlius Biotech’s first biosimilar has previously received approvals by the European Commission and National Medical Products Administration.

Shanghai Henlius Biotech (Henlius), a Shanghai-based biopharmaceutical company, announced the FDA approval of HERCESSI (HLX002; trastuzumab-strf), a trastuzumab biosimilar developed and manufactured by Henlius. HLX002 has been approved in the United States for adjuvant treatment of HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It has previously received approvals for commercialization by the European Commission (EC) and National Medical Products Administration (NMPA) in July 2020 and August 2020.

This is the company’s first FDA-approved biosimilar, adding to its growing portfolio. Herlius, formed in 2010, focuses on biologic therapies for oncology, autoimmune diseases, and ophthalmic diseases. As of this article’s publication, the company has launched five products in China, which two marketing approvals and 19 indications approved worldwide.The company is good manufacturing practice-certificated by China, the European Union, and US for the manufacturing of self-developed antibody drugs.

“Our patient-centered approach has led us to unwaveringly explore high-quality, effective, affordable, and accessible treatment options, and our determination to promote HLX02 in more than 40 markets around the world is Henlius' response to patients' concerns,” said Jason Zhu, executive director, chief executive officer and chief financial officer of Henlius, in a press release (1). “We look forward to reaching more patients in North America and providing them with more cost-effective access to high-quality biologics.”


Breast cancer is the second most diagnosed cancer, Henlius stated in the press release. More than 370,000 new cases of breast cancer will be diagnosed in the US in 2024, and around 15–20% of breast tumors are HER2-positive breast cancers (2). With gastric cancer, HER2 positivity ranges from 12–23% (3). Trastuzumab plays a significant role in HER2-positive breast and gastric cancer treatment. HLX002 was granted approval based on a package of analytical, pre-clinical, and clinical study data submitted by Henlius. This included comprehensive quality analytical studies, a Phase I pharmacokinetic similarity study, and a global multicenter Phase II clinical study.

“The approval of HERCESSI—our first biosimilar to be approved in the US—marks an important milestone for Accord BioPharma [Henlius’ business partner] in our efforts to improve access for patients," said Chrys Kokino, US president of Accord, in the Henlius press release. “Because breast and gastric cancers are among the most common types of cancer and cancer can have a high-cost burden for patients, there is a need to provide these patients with additional treatment options that may be more affordable, such as biosimilars.”


  1. Shanghai Henlius Biotech, Henlius Trastuzumab Receives FDA Approval in the United States. Press Release, Apr. 29, 2024.
  2. American Cancer Society. Cancer Facts and Figures 2024. American Cancer Society, 2024.
  3. National Comprehensive Cancer Network. NCCN Guidelines for Gastric Cancer, Version 1.2024. NCCN, 2024.