Accord BioPharma receives FDA OK for 420 mg strength of Hercessi

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, focused on the development of oncology, immunology and critical care therapies, has obtained the Food and Drug Administration’s approval of a 420 mg strength of Hercessi (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. This paves the way for the company to commercially launch its first biosimilar in the United States in early 2025.

"At Accord BioPharma, we are deeply committed to helping patients gain access to the medicines they need, and we will continue our efforts to help all stakeholders recognize the promise of biosimilars," said Chrys Kokino, U.S. president of Accord. "Although each cancer patient is unique, the cost of oncologic therapies often adds a significant burden on top of other existing challenges. We strive to respond to those needs with biosimilars like Hercessi."

Hercessi is indicated for the adjuvant treatment of adult patients with HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

[Read more: Prioritizing Lower-Priced Biosimilar Medications]

The company said, in general, HER2 cancers are particularly aggressive and respond well to targeted treatment. Hercessi works by binding to and inactivating the HER2 receptor, slowing down cell replication.

"Our organization has long been at the forefront of the biosimilar industry, bringing treatments to regulated markets such as the EU. The FDA's approval of both strengths of Hercessi marks the beginning of Accord BioPharma's journey to bring a portfolio of biosimilars to the U.S. that can help achieve significant savings," said Binish Chudgar, vice chairman and managing director, Intas Pharmaceuticals. "The vast global biosimilars experience within our organization, combined with the passion and drive of our employees, has helped us achieve this important milestone, which will expand the range of affordable treatment options for breast and gastric cancer patients."

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

[Read more: Accord BioPharma get FDA OK for Herceptin biosimilar]

Jason Zhu, executive director and CEO of Henlius said, "The strength and success of our collaboration with Accord continues with the approval of the 420 mg strength of Hercessi. This represents an important step in our journey to meet the needs of patients with innovative, high quality, and affordable therapeutics."

[Read more: A new environment for biosimilars]