BP11

BP11 is a proposed biosimilar of omalizumab, a recombinant DNA-derived humanized IgG1 kappa monoclonal antibody. Developed by Reliance Life Sciences, BP11 is designed to bind specifically to free human immunoglobulin E (IgE) in the blood and interstitial fluid. By binding to the Cε3 domain of the IgE molecule, it prevents IgE from interacting with the high-affinity FcεRI receptor on the surface of mast cells and basophils. This inhibition reduces the release of inflammatory mediators such as histamine and leukotrienes, which are central to the allergic cascade. In Phase 1 clinical trials, BP11 demonstrated pharmacokinetic and pharmacodynamic equivalence to both US- and EU-sourced reference omalizumab (Xolair) in healthy subjects, with a safety and immunogenicity profile consistent with the reference products.

Other names

omalizumab biosimilar