Advanz Pharma Holdco Limited (Advanz Pharma), a UK-headquartered global pharmaceutical company focused on specialty, hospital, and rare disease medicines in Europe, and Alvotech, a global biotech company specialising in the development and manufacture of biosimilar medicines, have announced that the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) 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.”

Joseph McClellan, Chief Scientific and Technical Officer of Alvotech, added, “This development brings us a step closer to offering an important therapy in respiratory disease more broadly. It is excellent news for our partnership with Advanz Pharma, patients, and caregivers. Alvotech remains committed to leveraging its end-to-end biosimilars platform to expand access to affordable biologic medicines.”

AVT23 was developed by Alvotech in collaboration with Kashiv BioSciences LLC. Advanz Pharma holds commercial rights for the product across the European Economic Area (European Union, Norway, Iceland, and Liechtenstein), the UK, Switzerland, Canada, Australia, and New Zealand. Earlier this year, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) also accepted a Marketing Authorisation Application for AVT23.

Omalizumab, the active ingredient in Xolair, is a prescription biologic used to improve the control of severe persistent allergic asthma in patients aged six years and older when blood tests confirm immunoglobulin E (IgE) involvement. It is also indicated for chronic spontaneous urticaria (long-term itchy rash) and severe chronic rhinosinusitis with nasal polyps.

AVT23 is a proposed biosimilar to Xolair (omalizumab), a humanised monoclonal antibody that targets free immunoglobulin E (IgE). Xolair is currently indicated for severe persistent allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps (CRSwNP). AVT23 remains an investigational product and has not yet received regulatory approval in any country. Biosimilarity has not been established or claimed by regulatory authorities.

Alvotech, founded by Robert Wessman, is dedicated exclusively to the development and manufacture of biosimilars for patients worldwide. The company collaborates globally with partners including Teva Pharmaceuticals, STADA Arzneimittel, Fuji Pharma, Dr. Reddy’s, Biogaran, Cipla, Cipla MedPro, JAMP Pharma, Yangtze River Pharmaceutical, DKSH, and YAS Holding.