Omalizumab biosimilar is under clinical development by Synermore Biologics and currently in Phase III for Chronic Urticaria Or Hives. According to GlobalData, Phase III drugs for Chronic Urticaria Or Hives have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. 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 (SYN-008) is under development for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyps and chronic idiopathic urticaria or hives. It is administered through subcutaneous route. Omalizumab is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human immunoglobulin E (IgE).
Synermore Biologics overview
Synermore Biologics (Synermore) is a biotechnology company that researches and develops biosimilar monoclonal antibodies. It develops its products in the therapeutic areas of oncology, immune disorders and infectious diseases. Its pipeline products include SYN004, SYN008, SYN125, SYN050, SYN060, SYN112, SYN109 and others. Synermore has developed technologies and platforms necessary for the development and production of therapeutic monoclonal antibodies including preparation and screening of hybridomas, antibody engineering and humanization, cell line construction and screening, CHO cell based culture platforms for high-density antibody expression, fermentation and purification, advanced analytical technologies for antibody characterization, and antibody drug formulation. The company also operates though its office located in Suzhou, China. Synermore is headquartered in Taipei City, Taiwan.
For a complete picture of Omalizumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.