– First ready-to-use, subcutaneous formulation of Bortezomib now available

– Marks Amneal’s fourth 505(b)(2) injectable product launch in the last year

BRIDGEWATER, N.J.–(BUSINESS WIRE)– Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and Shilpa Medicare Limited (“Shilpa”) today announced the U.S. launch of BORUZU™, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) 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. BORUZU has a unique J-code.

“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, Biosimilars and Branded Oncology.

“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 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.
The most commonly reported adverse reactions for BORUZU™ in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia.

For full prescribing information, see package insert located here.