Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

"The promise of HLX02's reference product—Herceptin¹—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 Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. "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." 

HLX02 was originally developed by Accord's business partner Shanghai Henlius Biotech, Inc. headquartered in Shanghai, China. In 2021, Henlius granted Accord BioPharma the exclusive rights to develop and commercialize HLX02 in the U.S. and Canada.

Approved in more than 30 countries, HLX02 was approved for commercialization by the European Commission (EC) and China's National Medical Products Administration (NMPA) in July 2020 and August 2020, respectively, for the same indications as the innovator product.

The BLA submission is based on robust structural and functional analytical comparison data using multiple orthogonal techniques and head-to-head clinical studies between HLX02 and the reference trastuzumab, including comparative analytical studies, nonclinical studies, a phase 1 PK similarity study and a global multicentric phase 3 safety, efficacy and immunogenicity study in relevant patient populations, which compared HLX02 to the reference trastuzumab. The clinical results demonstrated that HLX02 and reference trastuzumab are highly similar in terms of quality, safety, and efficacy.

Accord BioPharma has already received BLA approval on two other biosimilars, and the company plans to introduce several additional biosimilars to the U.S. market in the next five years.