In a major step toward improving global pandemic preparedness, Swiss pharmaceutical giant Roche and the Medicines Patent Pool (MPP) have signed a voluntary licensing agreement to expand access to the influenza antiviral drug Xofluza (baloxavir marboxil) across 129 low and middle-income countries (LMICs).
The agreement will allow selected generic drug manufacturers to develop, manufacture, and supply affordable versions of baloxavir marboxil, a single-dose oral treatment used against influenza. The medicine is already recommended by the World Health Organization and approved by regulators including the U.S. FDA and the European Medicines Agency.
Baloxavir has gained attention because of its ability to work against certain influenza strains that are resistant to older antiviral medicines. Experts believe broader access to such treatments could strengthen healthcare systems in vulnerable regions during seasonal flu outbreaks and future pandemics.
Under the collaboration, Roche will provide technical support including access to data packages, reference products for bioequivalence studies, and limited regulatory assistance. However, generic manufacturers will independently handle approvals and production processes.
MPP has also launched an Expression of Interest process to identify qualified manufacturers capable of supplying the medicine in licensed territories. The initiative is expected to create diversified manufacturing capacity and improve equitable access to influenza treatment, especially in regions where antiviral availability remains limited.
Global health leaders have welcomed the agreement as an important example of how voluntary licensing can improve access to innovative medicines while supporting preparedness for future health emergencies.
