Alvotech, Kashiv Biosciences, and Advanz Pharma Collaborate to Bring Affordable Biosimilar to Market
Reykjavik, Iceland, Piscataway, N.J., and London, March 26, 2025 – In a groundbreaking collaboration, Alvotech, a global biotech company specializing in the development and manufacturing of biosimilar medicines, Kashiv Biosciences LLC, a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma, a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, announced today that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab).
Xolair is a biologic indicated for the treatment of severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Global sales of Xolair in 2024 were estimated to be approximately USD $4.4 billion [1].
What is a Biosimilar?
A biosimilar is a biological product that is highly similar to an existing approved biologic, known as a reference product. Biosimilars are intended to provide more affordable treatment options for patients, as they typically cost less than the reference product due to increased competition in the market.
The Collaboration between Alvotech, Kashiv Biosciences, and Advanz Pharma
The collaboration between Alvotech, Kashiv Biosciences, and Advanz Pharma brings together the expertise of three companies to bring AVT23 to market. Alvotech’s strength lies in its advanced technology and capabilities in the development and manufacturing of biosimilars. Kashiv Biosciences contributes its deep understanding of the regulatory landscape and clinical development expertise. Advanz Pharma, with its focus on specialty, hospital, and rare disease medicines, will bring its commercialization expertise to the table.
Impact on Patients
The acceptance of the marketing application for AVT23 by the MHRA is a significant step towards making a more affordable treatment option available for patients with severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. If approved, AVT23 could provide a cost-effective alternative to Xolair, making it more accessible to a larger patient population.
Impact on the World
The development and approval of biosimilars like AVT23 have the potential to revolutionize the healthcare industry by increasing competition and driving down prices for biologic medications. According to a report by MarketsandMarkets, the biosimilars market is projected to grow from USD $24.5 billion in 2020 to USD $94.4 billion by 2025, at a CAGR of 25.3% [2].
Conclusion
The collaboration between Alvotech, Kashiv Biosciences, and Advanz Pharma to bring AVT23, a proposed biosimilar to Xolair, to market is an exciting development in the world of biotech. If approved, AVT23 has the potential to provide a more affordable treatment option for patients with severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Furthermore, the continued development and approval of biosimilars have the potential to revolutionize the healthcare industry by increasing competition and driving down prices for biologic medications.
- Alvotech, Kashiv Biosciences, and Advanz Pharma announce acceptance of marketing application for AVT23, a proposed biosimilar to Xolair
- AVT23 is a proposed biosimilar to Xolair, a biologic indicated for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps
- Global sales of Xolair in 2024 were approximately USD $4.4 billion
- Biosimilars are intended to provide more affordable treatment options for patients
- Collaboration between Alvotech, Kashiv Biosciences, and Advanz Pharma brings together expertise in development, manufacturing, regulatory landscape, and commercialization
- Acceptance of marketing application is a significant step towards making a more affordable treatment option available for patients
- Biosimilars market projected to grow from USD $24.5 billion in 2020 to USD $94.4 billion by 2025
Sources:
- [1] GlobeNewswire. Alvotech, Kashiv Biosciences, and Advanz Pharma Announce Acceptance of Marketing Application for Proposed Biosimilar to Xolair® (omalizumab) by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). March 26, 2025.
- [2] MarketsandMarkets. Biosimilars Market by Type (Monoclonal Antibodies, Fusion Proteins, and Others), Application (Oncology, Neurology, Rheumatology, and Others), and Region – Global Forecast to 2025.
