Shilpa Medicare Secures USFDA Nod for Liquid Bortezomib Injection

On August 27, 2024, Shilpa Medicare Ltd announced the USFDA approval of its second New Drug Application (NDA) [505(b)(2)] for Bortezomib Injection. This injectable product, approved for both subcutaneous and intravenous use, is available as a single-dose vial containing 3.5 mg/1.4 mL (2.5 mg/mL) of Bortezomib.

Notably, it is the first liquid form of Bortezomib Injection approved by the USFDA, offering a convenient ready-to-use option for subcutaneous administration, a marked improvement over the reference product Velcade®, which is a lyophilised injection requiring reconstitution before use.

Bortezomib Injection is a proteasome inhibitor containing the antineoplastic agent Bortezomib. It is approved to treat adult patients with multiple myeloma and mantle cell lymphoma, two serious and challenging types of cancer. The ability to administer the drug subcutaneously without prior reconstitution offers healthcare providers a significant advantage, reducing preparation time and potential errors associated with the reconstitution process.

Shilpa Medicare’s Bortezomib Injection will be marketed in the United States by its business partner, Amneal Pharmaceuticals LLC. The current U.S. market for lyophilised Bortezomib, which this new liquid formulation aims to compete with, is valued at approximately USD 95 million as of Q4 2023.

Commenting on this development, the Managing Director of Shilpa Medicare Limited, Mr Vishnukant Bhutada, said, “This second NDA approval in the US market from our novel injectable portfolio is a testament of our capabilities and commitment to introduce patient-centric solutions that enhance compliance and ease of administration. I am very pleased to see that our relentless endeavour and self-belief of investing in various value-added products across different segments have started paying off with monetisation opportunities being created in each of the segments, laying a stronger foundation for the future.”

On August 27, 2024, the share price of Shilpa Medicare opened at ₹740.10, touching the day’s high at ₹797.90, as of 2:03 PM on the NSE.

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