Roche Partners with UN-Backed Group to Expand Global Access to Influenza Drug Xofluza
Key Insights
Roche and the Medicines Patent Pool (search) signed a licensing agreement to expand access to Xofluza, an influenza antiviral drug, across 129 low- and middle-income countries.
The deal allows generic manufacturers to develop and supply the WHO-recommended treatment, which has shown effectiveness against flu strains resistant to older antiviral classes.
Under the agreement, Roche will provide data packages, reference products for bioequivalence studies, and regulatory support to accelerate generic drug development.
Roche and the Medicines Patent Pool (search) have signed a licensing agreement to expand access to the Swiss drugmaker's influenza drug, Xofluza, in low- and middle-income countries, the organizations announced on Monday. The deal aims to boost supply during seasonal outbreaks and potential pandemics across 129 countries where access to flu medicines remains limited.
Generic Manufacturing Initiative
The agreement will allow generic drugmakers to develop, manufacture and supply the antiviral pill across the designated countries, creating additional supply channels in underserved regions. The Medicines Patent Pool (search), a United Nations-backed public health group, said it would invite expressions of interest from manufacturers to produce the drug under license.
Xofluza is used to treat flu in patients who have had symptoms for no more than two days. The treatment, which is recommended by the World Health Organization and approved by regulators in the United States and Europe, has shown effectiveness against some flu strains resistant to older antiviral classes, making it an important tool in managing outbreaks.
Regulatory Support and Development
Under the agreement, Roche will provide licenses with access to data packages, reference products for bioequivalence studies and certain regulatory support to help accelerate the development of the drug's generic versions. Manufacturers will independently handle their own approval processes.
"This public health-oriented agreement is an important step towards further improving access to influenza treatment in LMICs," said MPP Executive Director Charles Gore, adding that it aimed to ensure tools and manufacturing capacity are in place before the next health emergency.
Market Context
In October, Roche launched direct-to-consumer U.S. sales of Xofluza at a discounted cash price of $50, following similar moves by rivals as they scramble to address pressure from the Trump administration to lower prescription drug prices paid by Americans.