Amneal and Shilpa Announce FDA Approval of Ready-to-Use Bortezomib

Amneal Pharmaceuticals, Inc., a U.S.-based global pharmaceutical company, and Shilpa Medicare Limited, an India-based pharmaceutical firm, have announced the approval of BORUZU™ by the U.S. Food and Drug Administration (FDA). BORUZU, a new presentation of bortezomib, is designed for subcutaneous or intravenous administration and simplifies the preparation process for oncology treatments.

BORUZU is a proteasome inhibitor used to treat multiple myeloma and mantle cell lymphoma. Unlike the existing branded product Velcade®, which requires reconstitution from a lyophilized powder, BORUZU is ready-to-use, eliminating several preparation steps. Shilpa Medicare developed the molecule, while Amneal Pharmaceuticals will handle its manufacturing and commercialization. BORUZU is anticipated to be available with a unique J-code in the second quarter of 2025.

Sean McGowan, Vice President of Biosimilars and Branded Oncology at Amneal, highlighted the significance of this new product. He noted that BORUZU represents the fourth 505(b)(2) injectable approval for Amneal this year. McGowan emphasized the importance of these ready-to-use injectable presentations in reducing pharmacy preparation steps for oncology providers, thereby enhancing clinical efficiency. He expressed Amneal's commitment to expanding its portfolio of branded oncology products to improve access for patients.

Vishnukant Bhutada, Managing Director of Shilpa Medicare, echoed these sentiments, noting that BORUZU is the second New Drug Application (NDA) approval in the U.S. from Shilpa's novel injectable portfolio. Bhutada emphasized that the development of pharmacy-efficient solutions like BORUZU aligns with Shilpa’s mission to introduce innovative pharmaceutical products that address significant healthcare needs. He underscored the company's continuous efforts to develop unique pharmaceutical solutions aimed at improving patient care.

In clinical studies, the most commonly reported adverse reactions for BORUZU included asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, fever, thrombocytopenia, psychiatric disorders, anorexia, decreased appetite, neutropenia, neuralgia, leukopenia, and anemia.

IQVIA reported that the annual U.S. sales for bortezomib reached approximately $96 million for the 12 months ending in December 2023.

Amneal Pharmaceuticals, headquartered in Bridgewater, NJ, is known for its extensive portfolio of over 280 generic and specialty pharmaceuticals. The company’s Generics segment is expanding into complex product categories and therapeutic areas, including injectables and biosimilars. Meanwhile, its Specialty segment focuses on branded pharmaceuticals targeting central nervous system and endocrine disorders. Amneal also distributes pharmaceuticals and other products to the U.S. federal government, retail, and institutional markets through its AvKARE segment.

Shilpa Medicare, established in 1987, specializes in active pharmaceutical ingredients (APIs) and formulations for generic medications, particularly in oncology. The company is also expanding into novel drug delivery systems and biotech products, while broadening its focus to other therapeutic areas.

This collaboration between Amneal and Shilpa aims to provide innovative, efficient pharmaceutical solutions that enhance patient care and streamline clinical operations. The introduction of BORUZU exemplifies this commitment, offering a ready-to-use formulation that simplifies the treatment process for serious conditions like multiple myeloma and mantle cell lymphoma.

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