Accord BioPharma get FDA OK for Herceptin biosimilar
Shanghai Henlius Biotech’s partner, Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, has received permission from the Food and Drug Administration for Hercessi (HLX02, trastuzumab-strf), which is a biosimilar to Herceptin.
The product has been approved 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. HLX02 is a China-developed monoclonal antibody biosimilar approved in China, the European Union and the U.S., with previous approvals for commercialization by the European Commission and National Medical Products Administration in July 2020 and August 2020, respectively.
Jason Zhu, executive director, CEO and chief financial officer of Henlius said,"Henlius independently developed HLX02 in accordance with the NMPA, the European Medicines Agency, 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."
[Read more: Prioritizing Lower-Priced Biosimilar Medications]
"Our first FDA-approved biosimilar is an important achievement for our U.S. specialty business, but we're just getting started. 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 at Intas Pharmaceuticals. "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."
"The approval of Hercessi—our first biosimilar to be approved in the U.S.—marks an important milestone for Accord BioPharma in our efforts to improve access for patients," said Chrys Kokino, U.S. president of Accord. "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."
[Read more: A new environment for biosimilars]