The race to make biologic therapies more accessible in Europe just gained momentum. Advanz Pharma and Alvotech announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application (MAA) for AVT23, a proposed biosimilar to Xolair® (omalizumab)—a key step toward regulatory approval.

Xolair, used to treat severe allergic asthma and chronic skin and sinus conditions, has long been one of the most recognized biologics in respiratory and immunological care. A biosimilar alternative could significantly lower costs and expand patient access across Europe’s healthcare systems.

A Strategic Collaboration
Developed by Alvotech in collaboration with Kashiv BioSciences LLC, AVT23 is the latest in a growing pipeline of biosimilars designed to challenge blockbuster biologics. Advanz Pharma, which has licensed commercial rights for the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand, will handle market distribution once approval is secured.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) had already accepted an MAA for AVT23 earlier this year, positioning the therapy for potential multi-market rollout in the near future.

Industry Momentum
“The EMA’s acceptance marks an important milestone in our mission to expand access to high-quality, affordable biologic medicines,” said Nick Warwick, Chief Medical Officer at Advanz Pharma.

Joseph McClellan, Chief Scientific and Technical Officer at Alvotech, echoed the sentiment, noting that the milestone “brings us a step closer to offering this important therapy in respiratory disease more broadly.”

Why It Matters
The global biosimilars market continues to surge as pharmaceutical companies and healthcare systems look for cost-efficient alternatives to branded biologics. For Advanz and Alvotech, AVT23 represents not just a commercial opportunity but a statement on the evolving balance between innovation, affordability, and patient access.

If approved, AVT23 could mark another significant entry in Europe’s biosimilar landscape—potentially intensifying competition for biologics manufacturers while advancing broader availability of life-improving therapies.

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