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Associated Press
26-03-2025
- Business
- Associated Press
UK Medicines and Healthcare Products Regulatory Agency has Validated and Accepted the Marketing Authorization Application for ADL-018, a Proposed Biosimilar of Xolair® (omalizumab)
Kashiv BioSciences, LLC ('Kashiv' or the 'Company') today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application (MAA) for ADL-018, the Company's proposed biosimilar for Xolair® (omalizumab). The acceptance marks a critical milestone in our commitment to developing cost-effective therapies to patients with moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria. The MAA is supported by a comprehensive data package, including extensive analytical, preclinical, pharmacokinetic, pharmacodynamic, safety, and immunogenicity studies demonstrating that ADL-018 is highly similar to the reference product, Xolair®, in terms of quality, safety, and efficacy. 'The MHRA's acceptance of the MAA for ADL-018 brings us one step closer to offering patients in the UK a cost-effective alternative to Xolair ®,' said Chirag and Chintu Patel, Executive Chairman and Co-Founders of Kashiv Biosciences. 'This acknowledgement by the MHRA underscores our dedication to expanding access to vital biologic therapies and addressing unmet medical needs.' 'This represents an important step in the development of our proposed biosimilar to Xolair, with the key goal to increase patient access to an important biologic,' said Joseph McClellan, Chief Scientific Officer of Alvotech. 'We are pleased to see the MHRA's acceptance of the MAA for ADL-018, which reflects the strength of our scientific collaboration and the shared vision to increase access to high-quality, affordable biologics,' said Dr. Nick Warwick, Chief Medical Officer at ADVANZ PHARMA. 'This is a significant step forward in our mission to bringing biosimilar medicines to more patients across the UK and beyond.' Kashiv Biosciences has a robust pipeline of biosimilar products, reflecting their deep commitment to delivering high-quality therapeutic options. The acceptance for ADL-018 aligns with the Company's strategic goal to broaden the portfolio on a global scale. About Kashiv: Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together 'Kashiv BioSciences') operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL MANAGED CARE GENERAL HEALTH HEALTH CLINICAL TRIALS SOURCE: Kashiv BioSciences, LLC Copyright Business Wire 2025. PUB: 03/26/2025 08:45 AM/DISC: 03/26/2025 08:47 AM
Associated Press
25-02-2025
- Business
- Associated Press
Kashiv BioSciences, LLC Obtains Marketing Authorization for Pegfilgrastim Injection from Health Canada
PISCATAWAY, N.J.--(BUSINESS WIRE)--Feb 25, 2025-- Kashiv BioSciences, LLC ('Kashiv' or the 'Company') today announced that Health Canada has granted marketing authorization for its Pegfilgrastim Injection, enabling its commercial launch in this market. This marks an important step in Kashiv's strategy to expand access to high-quality biosimilars in global markets. Pexegra TM is a long-acting G-CSF biosimilar indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic drugs. The marketing authorization follows a rigorous regulatory review by Health Canada, ensuring that Kashiv's Pegfilgrastim Injection meets the stringent quality, safety, and efficacy standards comparable to the reference biologic. JAMP Pharma Group, Kashiv's licensing partner in Canada, will spearhead the distribution and commercialization efforts. 'The addition of the Pegfilgrastim Injection to our BIOJAMP ® portfolio reinforces our commitment to providing Canadian patients with access to high-quality, cost-effective biosimilar medications,' said Louis Pilon, CEO of JAMP Pharma Group. 'The marketing authorization of our Pegfilgrastim Injection by Health Canada highlights Kashiv BioSciences' expertise in the development of complex biologics and biosimilars,' said Dr. Chandramauli Rawal, Chief Operating Officer of Kashiv BioSciences. 'We are excited to partner with JAMP Pharma Group to expand access to high-quality biosimilars to patients in Canada.' This regulatory recognition underscores Kashiv BioSciences' commitment to meeting international standards in drug development. As part of its global strategy, Kashiv will continue to expand its partnerships and pursue marketing authorizations to bring innovative therapies to patients in need. About Kashiv: Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets. Kashiv BioSciences, LLC in the United States, and its subsidiaries in India (together 'Kashiv BioSciences') operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. About JAMP Pharma Group The JAMP Pharma Group is a Canadian organization headquartered in Boucherville, in the Greater Montreal area. Having experienced exceptional growth over the past ten years, the JAMP Pharma Group is present in all segments of the pharmaceutical market, with a portfolio of more than 350 molecules. SOURCE: Kashiv BioSciences, LLC Copyright Business Wire 2025. PUB: 02/25/2025 08:45 AM/DISC: 02/25/2025 08:47 AM
