Roche has signed a voluntary license agreement providing its popular influenza antiviral drug Xofluza (baloxavir marboxil) for generic drugmakers to copy in 129 developing countries.
The deal with the Medicines Patent Pool will enable generic supply of baloxavir in 129 low- and middle-income countries, “both supporting seasonal flu and broader pandemic preparedness and response efforts,” MPP said in a May 18 release.
The deal will create “additional supply pathways for equitable access, which is particularly important during a pandemic, when demand is the highest,” MPP, a United Nations-backed organization, said in the release.
As part of the Roche deal, MPP is seeking applications from qualified generic manufacturers with the required capacity to support the development and supply of generic Xofluza.
Once the generic makers are identified, Roche will provide access to a data package, reference Xofluza product for bioequivalence studies and necessary regulatory waivers. Each sublicensee will still be responsible for independently developing and producing its generic versions.
Ongoing outbreaks of hantavirus and Ebola have once again thrust pandemic preparedness into the spotlight.
As much as the Xofluza deal is about improving access to influenza treatment in low- and middle-income nations, it also “reflects a shared commitment to pandemic prevention, preparedness and response […] ensuring that the necessary tools and manufacturing capacity are in place before the next health emergency,” Charles Gore, executive director of MPP, said in a statement.
Roche CEO Thomas Schinecker added that the license is “an important step towards strengthening global health resilience, particularly in LMICs.”
Roche has first-hand experience with what a health crisis could look like for Xofluza demand. A surge in influenza cases in China in early 2025 sparked fears of a shortage as antiviral medications became difficult to find. In response, Roche redirected its Xofluza supply to the country to ensure stability.
China is not one of the 129 countries included in the latest Roche-MPP deal because the Swiss pharma “already has a strong presence in the country, including dedicated manufacturing and distribution capabilities for Xofluza,” a Roche spokesperson told Fierce.
“Our selection of countries for this voluntary license with MPP was a deliberate, strategic decision to prioritize regions where access challenges are the highest and populations are most vulnerable in the event of a potential outbreak,” the spokesperson added.
The unpredictability of each flu season has caused major fluctuations in Roche’s Xofluza sales. In the first quarter of 2026, Xofluza sales of 19 million Swiss francs hit 83% below analysts’ expectations, the biggest gap in the company’s earnings for the three months. Roche cited a weaker flu season and, consequently, a year-over-year decline in China as the reason for the drug’s sales decline.
As a follow-up to Roche’s Tamiflu, Xofluza was first approved in the U.S. in 2018 as a treatment for acute uncomplicated influenza and was later cleared for the prevention of the flu following contact with an infected person.
Through a “most favored nation” drug pricing deal recently signed with the Trump administration, Roche is offering Xofluza on the direct-to-consumer platform TrumpRx for $50 rather than the regular $168.
This isn’t the first time Roche has partnered with MPP, which pools intellectual property to facilitate generic supplies for underserved regions. Back in 2013, Roche agreed with MPP to provide Valcyte, a drug used to prevent and manage cytomegalovirus infections, at lower costs for people living with HIV in 138 developing countries.
Antivirals represent a big component of MPP’s licensing partnerships with the industry. The Unitaid-funded organization has made HIV medication deals with GSK and Gilead Sciences, and it also struck agreements for oral COVID-19 drugs from Pfizer and Merck & Co. during the pandemic.
Editor's Note: The story was updated to clarify the nature of Roche's 2013 Valcyte deal with MPP.