Amneal and Shilpa Launch BORUZU™: A Ready-to-Use Bortezomib Injection for Multiple Myeloma & Lymphoma

Amneal Pharmaceuticals and Shilpa Medicare have launched BORUZU™ in the U.S., a ready-to-use formulation of bortezomib injection for subcutaneous or IV administration. Unlike the lyophilized Velcade®, which requires reconstitution, BORUZU™ simplifies preparation, reducing compounding steps. BORUZU™ is a proteasome inhibitor used to treat multiple myeloma and mantle cell lymphoma. Shilpa developed the molecule, while Amneal handled manufacturing and commercialization.

"As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the U.S. launch of BORUZU™ in our oncology portfolio. This ready-to-use injectable marks a significant innovation for our customers by streamlining pharmacy preparation steps for clinicians while now carrying a unique J-code to facilitate reimbursement. Our commitment remains steadfast in delivering differentiated oncology products that enhance patient care and access," said Sean McGowan, Senior Vice President of biosimilars and Branded Oncology.

The product features a unique J-code for reimbursement purposes. The most common adverse reactions observed include fatigue, gastrointestinal issues (diarrhoea, nausea, constipation, vomiting), neuropathy, fever, and blood-related conditions such as thrombocytopenia, anaemia, and leukopenia.

Vishnukant Bhutada, Managing Director of Shilpa Medicare, stated, “This second NDA product being launched in the US market from our novel injectable portfolio demonstrates our capabilities and commitment to introduce pharmacy efficient solutions that enhance compliance 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.”