Glenmark Reports Positive Phase 1 Results on Biosimilarity of GBR 310 to Omalizumab

Glenmark Pharmaceuticals announced positive results in a Phase 1 study comparing biosimilar GBR 310 to omalizumab, marketed as Xolair® by Genentech and Novartis.  According to Glenmark, the study supports similarity in pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles.

Xolair® is an anti-IgE antibody indicated for treating certain patients with either moderate to severe persistent asthma or chronic idiopathic urticaria.  Glenmark announced that it is seeking approval of GBR 310 for the same indications as the reference product.

Download PDF