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FDA Approves New Herceptin Biosimilar for the Treatment of Multiple HER2-Overexpressing Cancers


Hercessi marks Accord BioPharma’s first biosimilar to be approved in the United States, with multiple indications for HER2-overexpressing breast and gastric cancers.

Blood sample for Her-2 or human epidermal growth factor receptor 2 PCR testing for breast cancer diagnosis. Image Credit: Adobe Stock Images/Saiful52

Image Credit: Adobe Stock Images/Saiful52

Accord BioPharma announced that the FDA has approved Hercessi (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast and gastric cancers. The treatment is also approved for metastatic gastric or gastroesophageal junction adenocarcinoma. According to the company, the approval was based on promising data that showcased Hercessi’s biosimilarity to Herceptin when it came to efficacy, safety, and quality. This includes three studies, one being a Phase III clinical efficacy study, and the other two being Phase 1 PK equivalence studies. All trials displayed safety profiles on par with Herceptin.1

"The approval of Hercessi—our first biosimilar to be approved in the US—marks an important milestone for Accord BioPharma in our efforts to improve access for patients," said Chrys Kokino, US president, Accord, in a 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."

The approval comes a year after the FDA accepted Accord’s Biologics License Application (BLA) of trastuzumab-strf HLX02 for the treatment of three HER2-overexpressing cancers. The treatment was originally developed by Shanghai Henlius Biotech, with exclusive rights to develop and commercialize HLX02 in the United States and Canada being granted to Accord in 2021.2

"The promise of HLX02's reference product—Herceptin—is well documented, and we're thrilled to announce this regulatory milestone as we work to provide patients increased options and access for treatment of serious conditions in oncology, immunology, and critical care," said Kokino, in a press release. "Biosimilars are key to making healthcare more affordable and accessible. We're working to develop the deepest portfolio of biosimilars to enhance the patient experience and improve the cost of care across the continuum."

According to the American Cancer Society, HER2-positive cancers typically grow and spread much quicker than those that are HER2-negative. Despite this, they are also more likely to respond positively to treatment from drugs that target the HER2 protein. An immunohistochemistry (IHC) test or fluorescence in situ hybridization test can be used to determine whether a patient is HER2-positive. If the test shows an IHC result of three or more, the cancer is indicated as HER2-positive.3

“Henlius independently developed HLX02 (or Hercessi in the US) in accordance with the NMPA, the European Medicines Agency (EMA), the FDA, and other international biosimilar guidelines. It is Henlius' first FDA-approved product. 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. We look forward to reaching more patients in North America and providing them with more cost-effective access to high-quality biologics,” said Jason Zhu, executive director, CEO, chief financial officer, Henlius, in the press release.


1. Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab) for the Treatment of Several Forms of HER2-Overexpressing Cancer. PR Newswire. April 29, 2024. Accessed April 29, 2024. https://www.prnewswire.com/news-releases/accord-biopharma-inc-announces-us-food--drug-administration-approval-of-hercessi-trastuzumab-strf-a-biosimilar-to-herceptin-trastuzumab-for-the-treatment-of-several-forms-of-her2-overexpressing-cancer-302129508.html

2. Accord BioPharma Announces U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar Trastuzumab HLX02. PR Newswire. April 5, 2023. Accessed April 29, 2024. https://www.prnewswire.com/news-releases/accord-biopharma-announces-us-fda-acceptance-of-biologics-license-application-for-proposed-biosimilar-trastuzumab-hlx02-301790459.html

3. Breast Cancer HER2 Status. American Cancer Society. Accessed April 29, 2024. https://www.cancer.org/cancer/types/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html

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