Ready-to-Use Boruzu (Bortezomib) from Amneal and Shilpa Approved by FDA

Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration.

Boruzu, a proteasome inhibitor, offers a more efficient approach to treating multiple myeloma and mantle cell lymphoma by eliminating the reconstitution process required for Velcade, the current branded version of bortezomib. This ready-to-use option significantly cuts down on preparation time, enhancing efficiency for healthcare providers.

Amneal, headquartered in Bridgewater, New Jersey, continues to push forward in the oncology space, with Boruzu marking its fourth 505(b)(2) injectable approval in 2024. Last month, Amneal also secured FDA approval for a range of injectable emulsions of propofol, an anesthetic facing chronic shortages, underscoring the company’s ongoing efforts to address critical supply challenges in the healthcare system.

The company has significantly ramped up its manufacturing capabilities, now supporting a portfolio of over 40 injectable products, many of which focus on oncology treatments. As part of its broader strategy, Amneal plans to release two to three branded oncology 505(b)(2) products annually, further strengthening its offering to healthcare providers.

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India-based Shilpa Medicare, the developer of the new bortezomib presentation, is known for its expertise in active pharmaceutical ingredients (APIs) and formulations, particularly in oncology. Partnering with Amneal, Shilpa aims to bring novel and impactful therapies to the US market, reinforcing its commitment to delivering innovative solutions for large patient populations.

Boruzu is expected to hit the market in the second quarter of 2025, accompanied by a unique J-code — which is an alpha numeric code assigned to certain non-oral drugs as part of the Healthcare Common Procedure Coding System (HCPCS) Level II — to streamline reimbursement processes. This will help healthcare providers seamlessly incorporate this ready-to-use solution into their clinical practice.

In clinical trials, the most common side effects of Boruzu included asthenic conditions (defined by weakness or lack of energy), gastrointestinal disturbances, peripheral neuropathy and hematological abnormalities. Further studies are planned to examine the long-term safety and efficacy of Boruzu, adding to the body of knowledge about its role in oncology care.

Boruzu’s approval aligns closely with Amneal’s vision of delivering pharmacy-efficient, ready-to-use solutions that simplify workflows and ultimately benefit both healthcare providers and patients.