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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.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
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.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.
