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EMA Accepts GSK’s Mepolizumab Indication Expansion Application for COPD

Mar 24, 2025

On 24 March 2025, GSK announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala® (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

Corresponding applications for the expanded indication have been made to China’s National Medical Products Administration (NMPA) (February 2024) and the US FDA (December 2024).

Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Ph 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 exclusive marketing rights of the drug across Latin America.