China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for its biosimilar version of Novartis’ (NYSE: NVS) Xolair (omalizumab) for review. This development marks a significant step towards expanding treatment options for patients with allergic asthma and chronic spontaneous hives in China.
Omalizumab’s Global Availability and Indications
Omalizumab, first approved in the US, is now commercially available in over 90 countries, including the European Union, for the treatment of allergic asthma and chronic spontaneous hives. In China, it has been approved for use in chronic spontaneous hives in adults and adolescents aged 6 years and above, as well as for moderate to severe allergic asthma in adults and adolescents aged 12 years and above who still experience symptoms after treatment with H1 antihistamines.
CSPC’s Biosimilar Product and Its Indications
CSPC’s biosimilar is a Category 3.3 biologic product indicated for the treatment of H1 chronic spontaneous hives in adults and adolescents aged 12 years and above who still have symptoms after antihistamine treatment. This biosimilar offers a potential alternative for patients in need of this critical therapy.
Market Competition and Patent Information
MabPharm Ltd’s (02181.HK) omalizumab α is also registered in China for use in treating immunoglobulin E (IgE)-mediated asthma. While Omalizumab’s patent is valid through 2040 in the US, there is no publicly available information regarding its patent status in China, which could impact the market dynamics for biosimilar products in the country.-Fineline Info & Tech
