Advanz Pharma And Alvotech Advance AVT23, A Xolair® (omalizumab) Biosimilar, In Europe

Advanz Pharma Holdco Limited, a UK-headquartered global pharmaceutical company focused on specialty, hospital, and rare disease medicines in Europe, and Alvotech, a global biotech company dedicated to developing and manufacturing biosimilar medicines, announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization 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."

AVT23 was developed by Alvotech in collaboration with Kashiv BioSciences LLC, and Advanz Pharma holds the commercial rights across multiple regions, including the European Economic Area (EEA), the UK, Switzerland, Canada, Australia, and New Zealand. Earlier this year, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) also accepted a Marketing Authorization Application for AVT23, marking another step forward in its global regulatory pathway.

"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.

Omalizumab, the reference biologic for AVT23, is a prescription biologic used to manage severe allergic asthma, chronic spontaneous urticaria (CSU), and severe chronic rhinosinusitis with nasal polyps (CRSwNP). The acceptance of AVT23’s MAA by both the EMA and MHRA represents a significant milestone in expanding access to biosimilar treatment options for patients suffering from these chronic inflammatory and allergic conditions.