• The Medicines Patent Pool (MPP) and Roche have signed a voluntary licence agreement to expand access to baloxavir marboxil (Xofluza®), an innovative antiviral treatment for influenza recommended by the World Health Organization (WHO) and approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA)
  • This agreement will enable generic manufacturers to develop, produce and supply baloxavir in 129 (LMICs), creating additional supply pathways for equitable access, which is particularly important during a pandemic, when demand is the highest
  • MPP is launching an Expression of Interest to identify qualified generic manufacturers with the required capacities to support development and supply.

18 May 2026, Geneva – The Medicines Patent Pool (MPP) and Roche today announced the signing of a voluntary licence agreement for baloxavir marboxil (Xofluza®). Baloxavir marboxil is an antiviral medicine approved for the treatment of uncomplicated influenza and for post-exposure prophylaxis across age groups starting from 3 weeks of age in some labels. The announcement comes as global health leaders convene during the seventy-ninth World Health Assembly, where pandemic preparedness and response remain a central priority.

The agreement aims to expand access to baloxavir marboxil in LMICs both supporting seasonal flu and broader pandemic preparedness and response efforts. By establishing diversified manufacturing capacity in LMICs, the collaboration between MPP and Roche marks an important step towards strengthening global health security for future influenza outbreaks and pandemics.

Baloxavir marboxil is a single-dose oral antiviral treatment that stops influenza viruses from multiplying early in the infection, effectively reducing the duration of both the disease and its window of infectiousness. Baloxavir marboxil’s differentiated mechanism is proven to be effective against strains that are resistant to other classes of antiviral medicines, contributing to a more resilient and diversified defence against the evolving threat of influenza. Baloxavir marboxil is included in the WHO clinical practice guidelines for influenza.

Charles Gore, Executive Director, Medicines Patent Pool (MPP) said: “This public health-oriented agreement is an important step towards further improving access to influenza treatment in LMICs, where the burden of respiratory diseases remains high and access to antivirals is often limited. It also reflects a shared commitment to pandemic prevention, preparedness and response, in line with global priorities being discussed at the World Health Assembly, ensuring that the necessary tools and manufacturing capacity are in place before the next health emergency. We look forward to working with generic manufacturers through our Expression of Interest to enable geographically distributed manufacturing of this treatment.”
Thomas Schinecker, CEO, Roche, said: “Our voluntary licensing agreement with the Medicines Patent Pool for baloxavir marboxil (Xofluza®) is an important step towards strengthening global health resilience, particularly in LMICs. This collaboration shows what can be achieved when different sectors work together to expand access while still protecting the rules that enable future medical discoveries. By combining our innovation with the reach and know-how of our partners, we can help health systems to be better prepared for future pandemics.
Dr Chikwe Ihekweazu, Executive Director of the WHO Health Emergencies Programme, World Health Organization, said: “This agreement is an important step towards improving equitable access to influenza antivirals and strengthening global pandemic preparedness. Expanding availability across low- and middle-income countries will help support more resilient health systems and more timely responses to future outbreaks. WHO welcomes this collaboration and its contribution to protecting at-risk populations worldwide.”

As part of the agreement, Roche will support sublicensees in collaboration with MPP, providing access to a foundational data package, reference products for bioequivalence studies, and necessary regulatory waivers. While these measures are designed to accelerate the development and availability of generic versions, sublicensees will operate independently to compile, draft, and maintain their own regulatory processes.

Dr Philippe Duneton, Executive Director of Unitaid, said: “Voluntary licensing is a proven mechanism to accelerate access to affordable, quality-assured medicines. Applying this approach to pathogens of pandemic potential, like influenza, will help shorten the path from innovation to access, particularly in lower-resource settings, while strengthening preparedness for future outbreaks and pandemics.”
Aggrey Aluso, Executive Director, Resilience Action Network Africa, said: “As a Civil Society Network of organizations in Africa and LMIC regions, working closely with communities most impacted by the health equity challenges, that exemplifies practical steps that are required to ensure equitable access to health products in future health emergencies, this agreement, concluded on public health terms and conditions, offers an important and practical example. Expanding voluntary licensing and sharing know-how to enable geographically diverse manufacturing of key health commodities is exactly what is needed to strengthen pandemic prevention, preparedness and response. This approach can help ensure that countries are better equipped to respond quickly and equitably when the next health crisis arises.”

Access the licence agreement

The press release is also available in French (translation by MPP).

MPP invites Expressions of Interest (EoI) from potential sublicensees for sublicences to manufacture and sell baloxavir in the licensed territory

Access the EoI portal

More information about the EoI process

About MPP

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of innovative medicines and other health technologies for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed health products and pool intellectual property to encourage generic manufacture and the development of new formulations.

To date, MPP has signed agreements with 23 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, one antiviral treatment for influenza, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.

MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada and Coefficient Giving. MPP’s activities in technology transfer are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, the Government of Flanders and SDC.

Visit our website and follow us on LinkedIn, X or Bluesky

All trademarks used or mentioned in this release are protected by law.

References:

https://www.roche.com/media/releases/med-cor-2025-04-25

https://www.nejm.org/doi/full/10.1056/NEJMoa2413156

Media contact

Medicines Patent Pool
Email: press@medicinespatentpool.org