Home / Biosimilars / Research / Phase I study suggests similarity of omalizumab biosimilar

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.

Related article
Glenmark gains approval for anti-epileptic generic

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: Glenmark

Comments (0)