China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’s Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb).
CSPC Pharma’s biosimilar product is described as the first omalizumab biosimilar developed as a Category 3.3 biologic product in China. It is indicated for the treatment of adult and adolescent (12 years and older) patients with chronic spontaneous urticaria who continue to experience symptoms despite treatment with H1 antihistamines. A head-to-head study has demonstrated that the biosimilar is highly similar to Xolair in terms of quality, safety, and efficacy, with no clinically significant differences. – Flcube.com
