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Phase I study suggests similarity of omalizumab biosimilar Posted 16/11/2018

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 25 July 2018 that results from a phase I study suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between Glenmark’s proposed omalizumab biosimilar GBR 310 and the originator product Xolair (omalizumab).

Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes. Unlike an ordinary anti-IgE antibody, it does not bind to IgE that is already bound by the high affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and antigen-presenting dendritic cells. The originator product Novartis’s Xolair (omalizumab) is indicated for the treatment of moderate to severe persistent asthma and chronic idiopathic urticaria despite antihistamine treatment [1].

The completed phase I study enrolled 168 healthy adult volunteers, randomized 1:1 to receive either a single 150 mg dose of GBR 310 subcutaneously (SC) or a single 150 mg dose of Xolair SC. The total duration of participation for each volunteer was approximately 127 days, including screening, in-house stay, outpatient and follow-up visits.

Glenmark received US Food and Drug Administration clearance for its first-in-human trial for GBR 310 in April 2017.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of omalizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-omalizumab

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Source: Glenmark

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