Health
Fidson to produce generic influenza drug, strengthen health security
Nigerian pharmaceutical giant, Fidson Healthcare Plc, has been selected to develop and manufacture a generic version of Roche’s influenza antiviral, baloxavir marboxil, for supply to 129 countries under a global voluntary licensing agreement.
The selection makes Fidson one of 11 manufacturers across nine countries chosen under a voluntary licensing agreement between the Medicines Patent Pool and Swiss pharmaceutical company Roche.
The move aims to expand access to influenza treatment, diversify medicine supply chains and strengthen preparedness for future outbreaks and pandemics.
The countries involved are Brazil, China, India, Indonesia, Malaysia, Nigeria, Uganda, Ukraine and Vietnam, with Fidson representing Nigeria among the regionally focused manufacturers.
The announcement came as global leaders gathered at the United Nations General Assembly in New York to discuss pandemic prevention, preparedness and response.
The manufacturers were announced at a side event organised by the MPP with the support of Roche, titled “Advancing pandemic preparedness through voluntary licensing, technology transfer, and local production.”
The event brought together representatives from governments, industry, international organisations, manufacturers and civil society to discuss ways of strengthening systems and needed partnerships before the next health emergency.
The agreement allows selected manufacturers to develop, manufacture and supply generic versions of baloxavir marboxil in 129 countries, covering nearly all low- and middle-income countries, subject to regulatory authorisation.
The development moves the Roche-MPP voluntary licence, signed in May 2026, into the product development and manufacturing phase, with the selected companies expected to work towards regulatory approval of quality-assured generic versions of the antiviral.
The Medicines Patent Pool said the arrangement was designed to build a more geographically diverse manufacturing base before the next health emergency, rather than relying on manufacturers to scale up only after an outbreak occurs.
The Executive Director of the MPP, Charles Gore, said the organisation would work with the selected manufacturers on product development and regulatory approval.
He further noted that the MPP aimed to make quality-assured generic baloxavir available as quickly as possible while combining global manufacturing capacity with regionally focused production.
“We are now moving into implementation with manufacturers across multiple regions. This is exactly the kind of work that needs to happen before, rather than during, a health emergency. We will now work closely with these manufacturers to support product development and regulatory approval, with the aim of making quality-assured generic baloxavir available as quickly as possible. By combining global manufacturing capacity with regionally focused production, we are helping build a more geographically diverse and resilient supply base for the future,” Gore said.
Also, the Vice President and Head of Global Policy, Roche, Tamara Schudel, said, “Moving from our initial agreement to actual sublicensing manufacturers today marks an important milestone and demonstrates what is possible when organisations lean in with trust, pragmatism, and a shared goal.
“It also demonstrates that voluntary partnerships are a critical pillar in pandemic preparedness, enabling a rapid and effective response. We are grateful to the Medicines Patent Pool and the manufacturing teams for their partnership; their dedication and technical collaboration will help build the diverse, resilient supply pathways needed for better pandemic preparedness and faster response.”
The Director for Africa, Resilience Action Network International, Aggrey Aluso, further stated, “Pandemic preparedness is about acting before a crisis hits. Strengthening regional manufacturing and building diverse supply and access pathways now can help ensure that low- and middle-income countries are not left waiting for essential tools when the next health emergency occurs. The progress on baloxavir is a practical example of the kind of preparedness we need.”
Under the agreement, the manufacturers will have access to a technical data package, reference products for bioequivalence studies and other support intended to facilitate product development and regulatory approval.
The MPP selected the manufacturers following an open Expression of Interest process launched after the licensing agreement with Roche was signed in May.
Applicants were assessed based on criteria including their technical and regulatory capacities and commitment to developing and manufacturing quality-assured baloxavir products.
The selection includes four manufacturers with a global presence, Laurus Labs and MSN in India, and Desano and Guilin Pharma (Fosun) in China, as well as seven regionally focused manufacturers in Brazil, Indonesia, Malaysia, Nigeria, Uganda, Ukraine and Vietnam.
The MPP said combining global and regionally focused manufacturers would help diversify supply pathways for influenza treatment, strengthen supply resilience and bring production capacity closer to the regions and populations intended to receive the medicines.
The Managing Director and Chief Executive Officer of Fidson Healthcare Plc, Biola Adebayo, described the selection as a validation of the company’s commitment to quality-assured pharmaceutical manufacturing, innovation and improved healthcare outcomes.
“Being selected by the Medicines Patent Pool as a sublicensee under the Roche-MPP voluntary licensing programme for baloxavir marboxil is both an honour and a validation of Fidson’s longstanding commitment to quality-assured pharmaceutical manufacturing, innovation, and improving healthcare outcomes,” Adebayo said.
He said Fidson was proud to contribute to efforts aimed at strengthening regional health security and preparedness for future health emergencies.
Adebayo further stated that the partnership reinforced the growing role of African manufacturers in the global health ecosystem.
“As an African healthcare company, we are proud to contribute to global efforts aimed at strengthening regional health security, enhancing preparedness for future health emergencies, and ensuring that life-saving medicines reach the patients who need them most.
“This partnership reinforces the growing role of African manufacturers in the global health ecosystem and underscores our commitment to delivering quality-assured, world-class healthcare solutions that add value to lives.
“We look forward to working with Roche, the Medicines Patent Pool, and other stakeholders to support broader access to this important antiviral medicine across eligible markets and contribute to a more resilient and equitable healthcare future,” the Fidson’s MD and CEO said.
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