Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., announced FDA approval of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), for HER2-overexpressing breast and gastric cancers. This approval expands treatment options for patients with these aggressive cancer types.
HERCESSI is approved for:
- Adjuvant treatment of HER2-overexpressing breast cancer.
- Treatment of HER2-overexpressing metastatic breast cancer.
- Treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Clinical Data Supporting Approval
The FDA approval was based on a comprehensive data package, including analytical, pre-clinical, and clinical studies. These studies demonstrated that HERCESSI and Herceptin are highly similar in terms of efficacy, safety, and quality. The clinical program included:
- Two Phase 1 comparative single-dose PK equivalence studies in healthy volunteers (HLX02-HV01 and HLX02-HV02).
- A 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 data showed no clinically meaningful differences between HERCESSI and Herceptin in the studied populations, supporting biosimilarity between the two therapies.
Safety Profile
The safety profile of HERCESSI is consistent with that of Herceptin. However, the prescribing information includes a boxed warning addressing potential risks, including:
- Cardiomyopathy: Trastuzumab products can result in cardiac failure and decreased left ventricular ejection fraction (LVEF), especially when administered with anthracyclines. Cardiac function should be evaluated before and during treatment, and HERCESSI should be discontinued for cardiomyopathy.
- Infusion Reactions, Pulmonary Toxicity: HERCESSI should be discontinued for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
- Embryo-Fetal Toxicity: Exposure during pregnancy can result in oligohydramnios, pulmonary hypoplasia, and neonatal death. Effective contraception is recommended.
Market Impact and Future Development
"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. A 420mg-strength version of HERCESSI is also in development, with an FDA decision anticipated in Q4 2024. Accord BioPharma plans to introduce several additional biosimilars to the U.S. market over the next five years, potentially offering significant savings to the healthcare system.
HERCESSI was originally developed by Shanghai Henlius Biotech, Inc., who granted Accord BioPharma exclusive rights to develop and commercialize HERCESSI in the U.S. and Canada in 2021.
