FDA OKs Accord BioPharma's HERCESSI for cancer therapy

Accord BioPharma, a division of Intas Pharmaceuticals focusing on specialty treatments, has secured approval from the US Food and Drug Administration (FDA) for the 420mg dosage of HERCESSI (trastuzumab-strf). This biosimilar is designed to treat cancers overexpressing the HER2 protein and is a counterpart to the existing drug Herceptin (trastuzumab). The FDA's green light paves the way for HERCESSI's commercial launch in the US, anticipated to occur in early 2025.

HERCESSI has been approved for several critical uses. It is indicated as an adjuvant therapy for adults with HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma. HER2-positive cancers are known for their aggressive nature, but they have shown significant responsiveness to targeted treatments like HERCESSI. This biosimilar works by inhibiting the HER2 receptor, thereby slowing down the replication of cancer cells.

The FDA's approval of HERCESSI was grounded in a thorough assessment of analytical, preclinical, and clinical data from multiple studies. These comprehensive evaluations demonstrated that HERCESSI closely matches Herceptin in terms of efficacy, safety, and quality. Key data came from two Phase I comparative single-dose pharmacokinetic trials involving healthy individuals, as well as a supportive Phase III clinical efficacy and safety comparability study conducted with patients suffering from HER2-overexpressing metastatic breast cancer.

HERCESSI was developed by Shanghai Henlius Biotech, a partner of Accord BioPharma. In 2021, Henlius granted Accord exclusive rights to develop and commercialize HERCESSI in both the US and Canada. It is worth noting that the FDA had previously approved a 150mg dosage of HERCESSI in April 2024.

Accord BioPharma is not stopping with HERCESSI; the company has also submitted biologics license applications for biosimilar versions of pegfilgrastim, filgrastim, and ustekinumab. These submissions further underscore the company's commitment to expanding its portfolio of biosimilar treatments.

Chrys Kokino, President of Accord BioPharma US, emphasized the company's dedication to improving patient access to essential medicines. He highlighted that while each cancer patient's situation is unique, the financial burden of oncologic therapies can be overwhelming. Biosimilars like HERCESSI represent a promising solution by potentially reducing treatment costs without compromising on efficacy or safety.

In summary, the FDA's approval of HERCESSI marks a significant milestone for Accord BioPharma as it gears up for the drug's commercial launch. The new biosimilar offers hope for patients with aggressive HER2-overexpressing cancers by providing a cost-effective alternative to existing treatments, thereby addressing both medical and financial challenges faced by cancer patients.