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Advanz Pharma Holdco Limited (Advanz Pharma), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe and Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair (omalizumab).
Nick Warwick, chief medical officer of Advanz Pharma said, "The EMA’s acceptance of the marketing application for AVT23 marks an important milestone in our mission to expand access to high-quality, affordable biologic medicines for patients across Europe. We look forward to working with Alvotech to bring this important therapy closer to the patients who need it."
"Bringing us a step closer to offering this important therapy in respiratory disease more broadly, is excellent news for our partnership with Advanz Pharma, patients and caregivers. Alvotech is focused on leveraging its end-to-end biosimilars platform in support of broader access to affordable biologic medicines," said Joseph McClellan, chief scientific and technical officer of Alvotech.
Alvotech developed AVT23 in collaboration with Kashiv BioSciences LLC, and Advanz Pharma has licensed commercial rights in the European Economic Area (European Union, Norway, Iceland and Lichtenstein), UK, Switzerland, Canada, Australia and New Zealand. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) accepted a Marketing Authorization Application for AVT23 earlier this year.
Omalizumab is a prescription biologic medicine used to improve the control of severe persistent asthma caused by an allergy and is used as an add-on to asthma treatment in patients from 6 years of age when blood tests show that immunoglobulin E (IgE) causes the condition. It is also used to treat long-term itchy rash (chronic spontaneous urticaria) and inflamed lining of the nose and sinuses with swellings in the nose (severe chronic rhinosinusitis with nasal polyps).
AVT23 is a proposed biosimilar to Xolair (omalizumab). Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E (IgE). Xolair, which contains omalizumab, is indicated for severe persistent allergic asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps (CRSwNP). AVT23 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Biosimilars, autoimmune disorders, eye disorders, osteoporosis, respiratory disease, cancer, Teva Pharmaceuticals, STADA Arzneimittel, Fuji Pharma. Dr. Reddy’s, Biogaran, Cipla, Cipla Med Pro, JAMP Pharma, Yangtze River Pharmaceutical, DKSH, YAS Holding,
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