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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.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Meta-Analysis Confirms Similar Safety, Efficacy Between Adalimumab Biosimilars, Humira
April 6th 2024A systematic review and meta-analysis of 7 randomized controlled trials found no significant differences in efficacy and safety indicators between adalimumab biosimilars and the reference product (Humira) for treatment of moderate to severe psoriasis.
