On 22 May 2025, GSK announced that the US FDA has approved Nucala® (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.
The FDA accepted GSK’s application for the indication expansion in December 2024. Corresponding applications have been accepted by the European Medicines Agency (March 2025) and China’s National Medical Products Administration (February 2024).
Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Phase 1 trials (according to the company’s pipeline), and is the subject of an exclusive commercialisation deal struck in March 2024 with Costa Rican healthcare product distributor SteinCares for the marketing rights of the drug across Latin America.