- The UK MHRA has accepted the marketing application for AVT23, a proposed biosimilar to Xolair® by Alvotech (ALVO) and partners.
- Xolair recorded global sales of $4.4 billion in 2024, highlighting significant market potential for AVT23.
- Strategic partnerships between Alvotech, Kashiv Biosciences, and Advanz Pharma drive the development and commercialization of AVT23.
Alvotech (NASDAQ: ALVO), along with Kashiv Biosciences and Advanz Pharma, announced a significant regulatory milestone achieved with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) accepting the marketing application for AVT23. This proposed biosimilar to Xolair® (omalizumab) is designed to treat severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps.
Xolair, the reference drug, generated approximately $4.4 billion in global sales in 2024. This substantial market presence underscores the commercial potential for AVT23 upon regulatory approval. The acceptance by MHRA marks an essential step in the regulatory review process, though it is distinct from formal approval.
The development of AVT23 is supported by the collaborative efforts of Alvotech, focusing on biosimilar creation, Kashiv Biosciences providing development expertise, and Advanz Pharma leveraging their commercialization capabilities. This tripartite partnership aims to expand patient access to biologic treatments while capturing a share of the lucrative market.
Previous agreements set the stage for this progress. A commercialization agreement was established between Alvotech and Advanz Pharma in February 2023, and expanded in May 2023 to include five additional biosimilar candidates. Furthermore, a licensing agreement for AVT23 between Alvotech and Kashiv was finalized in October 2023. These strategic partnerships not only support AVT23 but also bolster Alvotech's broader biosimilar pipeline.
