Shilpa Medicare Ltd.

The product is intended to treat multiple myeloma and will be launched with a unique J-code in the second quarter of next year. Credit: Nemes Laszlo/Shutterstock. The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals and Shilpa Medicare’s oncology product BORUZU for subcutaneous administration. BORUZU, the first ready-to-use version of bortezomib, is a proteasome inhibitor indicated to treat multiple myeloma and mantle cell lymphoma. The new product simplifies the preparation process compared to the currently available lyophilised powder form, which requires reconstitution before administration. BORUZU references Velcade, the branded lyophilised powder version of bortezomib. Developed by Shilpa, BORUZU will be manufactured and commercialised by Amneal. See Also: CMN-005 by CoImmune for Extranodal Marginal Zone B-Cell Lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma): Likelihood of Approval CMN-005 by CoImmune for Nodal Marginal Zone B-Cell Lymphoma: Likelihood of Approval The product will be launched with a unique J-code [alphanumeric codes used for non-oral medications] in the second quarter of 2025. Amneal Pharmaceuticals biosimilars and branded oncology vice-president Sean McGowan stated: “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.” In clinical studies, the most commonly reported adverse reactions linked to BORUZU treatment were anaemia, anorexia, asthenic conditions, constipation, decreased appetite, diarrhoea, leukopenia, nausea, neuralgia, neutropenia, peripheral neuropathy, psychiatric disorders, pyrexia, thrombocytopenia and vomiting. Shilpa Medicare managing director Vishnukant Bhutada stated: “This second NDA approval in the US market from our novel injectable portfolio is a testament to our capabilities and commitment to introducing pharmacy-efficient solutions that enhance preparation and have the potential to reduce patient wait times. “This development exemplifies Shilpa’s constant endeavour to work towards introducing novel first-of-its-kind pharmaceutical products that help improve the healthcare requirements of a large patient pool.” In August 2024, the FDA approved Amneal Pharmaceuticals‘ CREXONT extended-release capsules for Parkinson’s disease treatment .

BRIDGEWATER, N.J.--( BUSINESS WIRE )--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) and Shilpa Medicare Limited (“Shilpa”) announced U.S. Food and Drug Administration (FDA) approval 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 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, Biosimilars and Branded Oncology. “This second NDA approval in the US 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. 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 . According to IQVIA ® , U.S. annual sales for bortezomib for the 12 months ended December 2023 were approximately $96 million. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com . About Shilpa Shilpa Medicare is a specialized API and formulations focused pharmaceuticals company. Founded in 1987, India-based Shilpa develops, manufactures and markets active pharmaceutical ingredients (APIs) and formulations for generic medications across Oncology and other therapeutic areas. Further to consolidation in the field of oncology API and formulations, we are striving to put in our efforts in the field of novel drug delivery systems and biotech products along with widening our focus to other therapy areas. For more information, please visit www.vbshilpa.com . Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

The recommendation was based on data from the initial interim analysis of the Phase III KEYNOTE-A39 clinical trial. Credit: R Photography Background/Shutterstock. Merck & Co has received European Commission (EC) approval for the use of Keytruda (pembrolizumab) along with Padcev (enfortumab vedotin-ejfv) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma, a type of bladder cancer. The authorisation follows the European Society for Medical Oncology and the European Association of Urology’s endorsement of this combination therapy as the preferred initial treatment for these patients, regardless of their eligibility for platinum-based chemotherapy. The EC’s decision is in line with the positive recommendation from the Committee for Medicinal Products for Human Use received in July 2024. The recommendation was based on the data from the initial interim analysis of the Phase III KEYNOTE-A39 clinical trial, conducted in collaboration with Pfizer and Astellas. The open-label, multicentre, randomised, active-controlled study compared KEYTRUDA plus enfortumab vedotin to platinum-based chemotherapy. See Also: FDA approves Amneal and Shilpa’s oncology product BORUZU A quick guide to transferring a commercial drug product to a new fill-finish CDMO The combination showed statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS). At a median follow-up of 17.3 months, the combination therapy reduced the risk of death by 53% and disease progression or death by 55% versus platinum-based chemotherapy. The approval enables the marketing of KEYTRUDA in combination with enfortumab vedotin for this indication across all 27 European Union member states, along with Liechtenstein, Iceland, Norway and Northern Ireland. In December 2023, the combination therapy received approval in the US to treat locally advanced or metastatic urothelial cancer in adults. Merck’s research laboratories oncology, global clinical development head and senior vice-president Dr Marjorie Green stated: “For the first time in decades, adult patients with unresectable or metastatic urothelial carcinoma have the option of a potential new first-line standard of care that may help extend their lives. “We are pleased with the European Commission’s decision, and we look forward to being able to provide KEYTRUDA as part of this novel treatment regimen for this devastating disease to patients in the European Union.” The development comes after the EC approved MSD’s Winrevair (sotatercept) to be used as a combination therapy for functional class II or III pulmonary arterial hypertension. This content was updated on 25 January 2024