Global biotechnology company Alvotech SA (NASDAQ:ALVO) and UK pharmaceutical company Advanz Pharma announced on Monday that the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application for AVT23, a proposed biosimilar to Xolair (omalizumab).

AVT23 was developed by Alvotech in collaboration with Kashiv BioSciences LLC, with Advanz Pharma holding commercial rights in the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) accepted a separate Marketing Authorisation Application for AVT23 earlier this year.

Omalizumab is a prescription biologic used to manage severe persistent allergic asthma, chronic spontaneous urticaria, and severe chronic rhinosinusitis with nasal polyps.

AVT23 is designed as a humanised monoclonal antibody targeting free immunoglobulin E (IgE), providing a biosimilar alternative to Xolair. The EMA acceptance represents a key regulatory milestone for the commercialisation of AVT23 in Europe.