On May 16, 2016, Sorrento Therapeutics announced successful results from a Phase 2 and 3 clinical study for a biosimilar to Xolair. Xolair (omalizumab) is marketed by Genentech and Novartis to treat allergic asthma and chronic idiopathic urticaria (a chronic skin condition). Sorrento’s biosimilar product, dubbed STI-004, proved to be safe and efficacious in adults and adolescents suffering from allergic asthma when compared to placebo. The types and incidence rate of adverse events were similar to those seen for Xolair. Sorrento’s announcement had no information as to whether it has tested STI-004 to treat chronic idiopathic urticaria.
Sorrento has a licensing agreement with China-based Mabtech Limited, under which Sorrento will market four monoclonal antibody products, including the omalizumab biosimilar, in North America, Europe and Japan, while Mabtech will market the products in China. We previously reported on successful trials for two other biosimilars (cetuximab and infliximab) that are part of Sorrento’s agreement with Mabtech.
Stay tuned to Big Molecule Watch for more biosimilar news.