Roche signs landmark MPP agreement to increase Xofluza access in 129 countries

SWITZERLAND—Roche has signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) to expand access to its influenza antiviral medicine Xofluza (baloxavir marboxil) across 129 low- and middle-income countries (LMICs).

The agreement will allow selected generic manufacturers to develop and supply lower-cost versions of the treatment, strengthening both seasonal influenza management and global pandemic preparedness efforts.

The announcement comes as global health leaders gather for the seventy-ninth World Health Assembly, where pandemic prevention and response remain key priorities.

Through the agreement, Roche and MPP aim to build geographically diverse manufacturing capacity for influenza antivirals in regions that often face limited access to life-saving medicines during outbreaks.

Expanding manufacturing and access

Under the licensing arrangement, MPP has invited qualified generic drug manufacturers to submit applications to produce generic versions of Xofluza.

Once selected, sublicensees will receive support from Roche, including access to reference products for bioequivalence studies, regulatory waivers, and a foundational data package designed to speed up product development.

However, each manufacturer will remain responsible for independently developing, producing, and managing regulatory approvals for its own generic version of the medicine.

Baloxavir marboxil is a single-dose oral antiviral approved for the treatment of uncomplicated influenza and for post-exposure prevention in certain age groups, including children as young as three weeks in some markets.

Unlike older antivirals, the medicine works by blocking viral replication early in infection, helping reduce both the duration of illness and the period during which infected individuals can spread the virus.

The medicine has also demonstrated effectiveness against influenza strains resistant to other antiviral classes, making it an important addition to pandemic preparedness strategies.

The World Health Organization has included baloxavir marboxil in its clinical practice guidelines for influenza treatment.

Pandemic preparedness remains a priority

Charles Gore, Executive Director of MPP, described the agreement as a major step toward improving access to influenza treatment in countries where respiratory diseases continue to place a heavy burden on health systems.

He noted that the partnership also reflects a broader global commitment to pandemic prevention and preparedness by ensuring that manufacturing capacity and medical tools are established before future health emergencies emerge.

Roche CEO Thomas Schinecker said the agreement would help strengthen health resilience in LMICs while supporting innovation through collaboration between the private sector and global health organizations.

Meanwhile, Dr. Chikwe Ihekweazu, Executive Director of the WHO Health Emergencies Programme, welcomed the partnership, saying expanded access to influenza antivirals would support faster and more equitable outbreak responses worldwide.

The agreement follows heightened global concern over emerging infectious disease outbreaks, including Ebola and hantavirus cases reported in recent months.

Roche previously experienced surging demand for Xofluza during a severe influenza wave in China in early 2025, prompting the company to redirect supplies to stabilize availability.

Although China is not included in the latest licensing agreement, Roche said the country already has dedicated manufacturing and distribution infrastructure for Xofluza.

Sales of Xofluza have fluctuated significantly with changing flu seasons. In the first quarter of 2026, Roche reported sales of 19 million Swiss francs (US$23 million), which fell below analyst expectations due to a milder influenza season and lower demand in China.

Roche recently also announced that Xofluza would be offered through the TrumpRx direct-to-consumer platform in the United States for US$50, down from its regular list price of US$168.