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Celltrion Healthcare Advances Trials for Omalizumab Biosimilar
The product would target the lucrative, billion-dollar worldwide market for Xolair.
Celltrion Healthcare will initiate a phase 3 trial of its omalizumab biosimilar (CT-P39) candidate for the treatment of chronic idiopathic urticaria, a form of hives, based on a regulatory green light from the Republic of Korea’s Ministry of Food and Drug Safety.
CT-P39 references the Genentech and Novartis product Xolair, an injectable prescription drug that targets and blocks immunoglobulin E. It is approved in the United States, the European Union, and Japan for the treatment of adults and children with moderate-to-severe asthma and chronic hives. The drug had worldwide sales of $1.17 billion in 2019, a 13% increase from the year before.
According to Republic of Korea press reports, the CT-P39 trial would be conducted at 65 sites in 7 countries, with a target enrollment of 600 patients with chronic idiopathic urticaria. The end points are efficacy and safety demonstrated via comparison of CT-P39 and Xolair. Trial completion is anticipated by the 2023 half-year point.
A phase 1 pharmacokinetic trial was initiated for CT-P39 in 2019.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Long-Term Data Support Use of Eculizumab Biosimilar as Soliris Alternative in PNH
January 28th 2025Eculizumab biosimilar Elizaria demonstrates long-term safety and efficacy comparable with the reference product Soliris in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a Russian study that expanded on a previous phase 3 study.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Biosimilar Teriparatide Matches Forteo in Safety and Fracture Risk
January 23rd 2025Biosimilar teriparatide has been shown to be as safe and effective as its reference product for osteoporosis treatment, potentially enabling significant cost savings in Japan’s health care system while addressing persistent misconceptions about biosimilar quality.
A Banner Year for Biosimilars: The 19 FDA Approvals From 2024
January 21st 2025In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.
