China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received an additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’ Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). The latest approval is for the treatment of moderate to severe persistent allergic asthma, following an initial NMPA approval in October 2023 for chronic spontaneous urticaria in adults and adolescents aged 12 and older who remain symptomatic after H1 antihistamine treatment.
Product Profile
CSPC Pharma’s omalizumab biosimilar, classified as a Category 3.3 biologic product in China, is the first of its kind developed domestically. Head-to-head studies have demonstrated that the product is highly similar to Xolair in terms of quality, safety, and efficacy, with no clinically significant differences.
Strategic Outlook
The approval expands CSPC’s presence in the respiratory therapy market, offering a cost-effective alternative to Xolair. The company plans to leverage its biosimilar pipeline to address unmet needs in immunotherapy and allergen-related diseases.-Fineline Info & Tech
