Amneal Pharmaceuticals and Shilpa Medicare have secured the US Food and Drug Administration (FDA) approval for their cancer drug, Boruzu, for subcutaneous administration.
Boruzu is a biosimilar to bortezomib, the anti-cancer medication marketed by Japan’s Takeda Pharmaceutical, under the brand name Velcade.
Velcade is a proteasome inhibitor offered as a lyophilized powder and requires reconstitution before it is used for the treatment of multiple myeloma and mantle cell lymphoma.
Boruzu references Velcade, with ready-to-use subcutaneous administration reducing the compounding preparation steps required for administration.
Shilpa developed the drug molecule, and Amneal will manufacture and commercialise the product, with plans to launch it with a unique J-code in the second quarter of 2025.
Amneal Pharmaceuticals biosimilars and branded oncology vice president Sean McGowan said: “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.”
According to the analytics firm IQVIA, Velcade (bortezomib) made around $96m in US annual sales for the 12 months ended December 2023.
In clinical studies, the most common adverse reactions with Boruzu include asthenic conditions, diarrhoea, nausea, constipation, peripheral neuropathy, vomiting, and pyrexia.
The drug also caused thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia, and anaemia.
Furthermore, the drug is warned against peripheral neuropathy, hypotension, and cardiac toxicity.
Shilpa Medicare managing director Vishnukant Bhutada said: “This second NDA approval in the US market from our novel injectable portfolio is a testament of our capabilities and commitment to introduce pharmacy efficient solutions that enhance preparation and have the potential to reduce patient wait times.
“This development exemplifies Shilpa’s constant endeavour to work towards introducing novel first-of-its-kind pharmaceutical products that help improve the healthcare requirements of a large patient pool.”
