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FDA approves Amneal and Shilpa’s oncology product BORUZU

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals and Shilpa Medicare’s oncology product BORUZU for subcutaneous administration. BORUZU, the first ready-to-use version of bortezomib, is a proteasome inhibitor indicated to treat multiple myeloma and mantle cell lymphoma.

The new product simplifies the preparation process compared to the currently available lyophilised powder form, which requires reconstitution before administration. BORUZU references Velcade, the branded lyophilised powder version of bortezomib.

Developed by Shilpa, BORUZU will be manufactured and commercialised by Amneal. The product will be launched with a unique J-code [alphanumeric codes used for non-oral medications] in the second quarter of 2025.

Amneal Pharmaceuticals biosimilars and branded oncology vice-president Sean McGowan stated: “We are building a distinct branded oncology injectable portfolio. The approval of BORUZU is our fourth 505(b)(2) injectable approval this year. These ready-to-use injectable presentations are important innovations for oncology providers as they reduce the pharmacy preparation steps for clinicians. We look forward to bringing more branded oncology products to the market for providers while expanding access for patients.”

In clinical studies, the most commonly reported adverse reactions linked to BORUZU treatment were anaemia, anorexia, asthenic conditions, constipation, decreased appetite, diarrhoea, leukopenia, nausea, neuralgia, neutropenia, peripheral neuropathy, psychiatric disorders, pyrexia, thrombocytopenia and vomiting.

In August 2024, the FDA approved Amneal Pharmaceuticals‘ CREXONT extended-release capsules for Parkinson’s disease treatment.

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