Herceptin Biosimilar, Hercessi, Approved by FDA in Breast, Gastric Cancers

The Food and Drug Administration (FDA) has approved Hercessi (HLX02, trastuzumab-strf), a biosilimar to Herceptin (trastuzumab) for the adjuvant (postsurgical) treatment of HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, according to an announcement from developer and manufacturer, Henlius Biotech, Inc.

A biosimilar is a medication that, according to the FDA, is, “highly similar to a biological medication already approved by the FDA — the original biologic (also called the reference product).” The biosimilar's efficacy must be demonstrated via clinical trials that prove that the biosimilar does not have any clinically meaningful differences to the reference product.

“We aspire to deliver one of the deepest portfolios of biosimilars to patients and providers alike, and to help the U.S. health system achieve significant savings,” said Binish Chudgar, vice chairman and managing director, Intas Pharmaceuticals. Intas’ U.S. specialty division, Accord BioPharma, is Henlius’ business partner, according to the news release issued by Henlius.

“Our vision to make affordable medicines available forms the bedrock of the company, and this work advances that vision to provide value and promote access for all the key stakeholders we engage along the treatment journey,” said Chudgar.

HLX02 is a monoclonal antibody biosimilar approved in China, the European Union (EU) and U.S., with previous approvals from the European Commission (EC) and National Medical Products Administration (NMPA) in China in 2020, according to the news release.

“Henlius independently developed [Hercessi] in accordance with the NMPA, the European Medicines Agency (EMA), the FDA and other international biosimilar guidelines,” said Jason Zhu, executive director, chief executive officer and chief financial officer of Henlius, in the news release. “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.”

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