The U.S. Food and Drug Administration (FDA) has approved Accord BioPharma’s HERCESSI (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.
“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.”
HERCESSI is indicated 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. HER2 cancers in general are particularly aggressive cancer types that respond well to targeted treatment. HERCESSI works by binding to and inactivating the HER2 receptor, slowing down cell replication.
FDA approval was granted based on a comprehensive package of analytical, pre-clinical, and clinical data, which showed HERCESSI and its reference product, Herceptin (trastuzumab) are highly similar in terms of efficacy, safety, and quality. The clinical program for HERCESSI included three studies since 2015 to demonstrate pharmacokinetic (PK) comparability and clinical efficacy/safety similarity between HERCESSI and its reference product.
The studies include two Phase 1 comparative single-dose PK equivalence studies conducted in healthy volunteers (HLX02-HV01 and HLX02-HV02), and a supportive Phase 3, double-blind, randomized clinical efficacy and safety comparability study in patients with HER2-overexpressing metastatic breast cancer in combination with docetaxel (HLX02-BC01). The PK comparability and clinical efficacy/safety similarity exercised in HLX02-HV02 and HLX02-BC01 adheres to current biosimilar guidance from the FDA.
The safety profile of HERCESSI has been shown to be consistent with the safety profile for the reference product Herceptin. The data demonstrate that there are no clinically meaningful differences between HERCESSI and Herceptin in the populations studied and support biosimilarity between the two therapies.
HERCESSI was approved by the FDA at a dosage of 150mg. A 420mg-strength version of HERCESSI is also in development from Accord BioPharma, with an FDA decision anticipated in Q4 2024.
HERCESSI 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 HERCESSI in the U.S. and Canada.
