FDA has granted Orphan Drug Designation (ODD) to BORUZU™ (bortezomib injection), a proteasome inhibitor developed by Shilpa Medicare Limited and will be manufactured and commercialized by Amneal Pharmaceuticals for the treatment of multiple myeloma (MM) and mantle cell lymphoma (MCL).
BORUZU™ is a proteasome inhibitor and is bioequivalent to the branded product Velcade®. This new formulation eliminates the need for reconstitution, simplifying the administration process for healthcare providers and MM and MCL patients.
Sean McGowan, VP of Biosimilars and Branded Oncology, acknowledged a significant milestone with the approval of BORUZU™ as the fourth 505(b)(2) injectable this year for MM and MCL patients.
BORUZU™ reduced pharmacy preparation steps and highlighted our commitment to improving MM and MCL patient access and supporting providers with future oncology products.
Vishnukant Bhutada, MD of Shilpa, acknowledged the recent FDA approval and emphasized that this second NDA approval from a novel injectable portfolio validated Shilpa’s commitment to pharmacy-efficient solutions.
Bhutada noted that BORUZU™ development exemplified Shilpa’s efforts to introduce innovative pharmaceutical products meeting the evolving needs of a large MM and MCL patient population.
Source: Shilpa Medicare developed the molecule, and Amneal will manufacture and commercialize BORUZU™ in the U.S., with a set to launch in Q2 2025 and a unique J-code.
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