The FDA’s decision was based on pre-clinical and clinical data demonstrating that HERCESSI and Herceptin are highly similar. Credit: Alexander Raths/Shutterstock.com.

Accord BioPharma, the US speciality division of Intas Pharmaceuticals, has secured approval from the US Food and Drug Administration (FDA) for HERCESSI (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab).

The approval marks a significant milestone for the treatment of HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

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The therapy is indicated for the adjuvant treatment of HER2-overexpressing cancers.

The FDA’s decision was based on a comprehensive package of analytical, pre-clinical and clinical outcomes, demonstrating that HERCESSI and Herceptin are similar in terms of safety, efficacy and quality.

HERCESSI’s clinical programme included three trials aimed at showing pharmacokinetic comparability, clinical efficacy and safety similarity with its reference product.

The studies adhered to the FDA’s current biosimilar guidance, confirming the similarity between HERCESSI and Herceptin.

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HERCESSI has been approved at a 150mg dosage, with a 420mg-strength version currently in development which is expected to receive an FDA decision in the fourth quarter of 2024.

Its development was a collaborative effort with Shanghai Henlius Biotech, which granted Accord BioPharma exclusive rights for the US and Canada.

Accord US president Chrys Kokino stated: “The approval of HERCESSI — our first biosimilar to be approved in the US — marks an important milestone for Accord BioPharma in our efforts to improve access for patients.

“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.”

Accord BioPharma is also pursuing FDA approval for biosimilar versions of other drugs and plans to introduce additional biosimilars to the US market in the coming years.