Accord BioPharma, the speciality division of Intas Pharmaceuticals, has received US Food and Drug Administration (FDA) approval for 420mg HERCESSI (trastuzumab-strf), a biosimilar to reference product Herceptin (trastuzumab) to treat HER2-overexpressing cancers.
The approval will enable the commercial launch of the company’s first biosimilar in the US market, projected for early 2025.
HERCESSI is approved as an adjuvant treatment for adults with HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.
HER2 cancers are aggressive and have been shown to respond effectively to targeted treatments such as HERCESSI, which inhibits the HER2 receptor to slow cell replication.
The FDA’s decision was based on a comprehensive package of analytical, preclinical and clinical data from three studies.
These studies demonstrated that HERCESSI and Herceptin are similar in terms of efficacy, safety and quality.
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The data included results from two Phase I comparative single-dose pharmacokinetic trials in healthy subjects and a supportive Phase III clinical efficacy and safety comparability study in people with HER2-overexpressing metastatic breast cancer.
Accord BioPharma’s partner, Shanghai Henlius Biotech, developed HERCESSI.
In 2021, Henlius granted the exclusive rights to Accord for developing and commercialising HERCESSI in the US and Canada.
Initially, a 150mg dosage of HERCESSI was approved by the FDA in April 2024.
Accord BioPharma has also submitted biologics licence applications for biosimilar versions of pegfilgrastim, filgrastim and ustekinumab.
Accord BioPharma US president Chrys Kokino stated: “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 recognise the promise of biosimilars.
“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.”
