Omalizumab biosimilar is under clinical development by Glenmark Pharmaceuticals and currently in Phase I for Allergic Asthma. According to GlobalData, Phase I drugs for Allergic Asthma have a 78% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Omalizumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Omalizumab biosimilar overview

Omalizumab biosimilar (GBR-310) is  under development for the treatment of allergic asthma and chronic idiopathic urticaria. It is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody. It is administered through subcutaneous route.

Glenmark Pharmaceuticals overview

Glenmark Pharmaceuticals (Glenmark) focuses on the discovery and development of new chemical entities (NCEs). It develops and markets branded and generic formulations. The company’s formulations business encompasses therapeutic areas such as dermatology, respiratory, and oncology. It has also presence in other therapeutic areas such as diabetes, cardiovascular and oral contraceptives. The company manufactures and supplies active pharmaceutical ingredients (APIs). Glenmark has manufacturing facilities in India, Argentina, the US and Czech Republic. The company markets its products in North America, Japan, Latin America, Europe, India, Middle East North Africa (MENA), Asia and Russia, among others. Glenmark is headquartered in Mumbai, Maharashtra, India.

For a complete picture of Omalizumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.