On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for March, April and May 2025.
Among the applications to be reviewed is MSD’s clesrovimab (MK-1654, approved on 9 June 2025 as Enflonsia™ in the US; brand name yet to be confirmed in Australia) for the prevention of respiratory syncytial virus (RSV) in newborns and infants who are born during or entering their first RSV season. Clesrovimab has not yet been approved for any indication in Australia.
The TGA will also review an indication expansion for GSK’s Nucala® (mepolizumab) as an additional treatment for adults with chronic obstructive pulmonary disease (COPD). This indication was approved by the US FDA in May 2025, with corresponding applications being 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.