Amneal, Shilpa receive FDA nod for Boruzu

Amneal and Shilpa have received the Food and Drug Administration’s permission for Boruzu, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous administration. 

This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration.

Boruzu (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade, a lyophilized powder requiring reconstitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. 

[Related: Amneal touts 39 retail, injectable product launches in 2023]

Boruzu is expected to launch with a unique J-code in the second quarter of 2025.

“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,” said Sean McGowan, vice president of biosimilars and branded oncology.

“This second NDA approval in the U.S. 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 endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool,” said Vishnukant Bhutada, managing director of Shilpa Medicare.

[Read more: Amneal touts 26 generic new product launches in 2022]

Bortezomib had a market value of roughly $96 million for the 12 months ended December 2023, per IQVIA.