Fidson wins Roche-backed licence to make generic influenza drug for 129 countries
Fidson Healthcare Plc, a Nigerian pharmaceutical manufacturer, has been selected by the Medicines Patent Pool (MPP) as one of 11 manufacturers that will develop and produce generic versions of Roche’s baloxavir marboxil, potentially expanding access to the influenza treatment across 129 eligible countries.
The selection places Fidson among manufacturers from Brazil, China, India, Indonesia, Malaysia, Uganda, Ukraine and Vietnam under a voluntary licensing agreement between MPP and Roche. The agreement covers nearly all low- and middle-income countries, subject to regulatory approval.
The sublicensing arrangement is expected to expand manufacturing capacity for baloxavir marboxil while creating a more geographically diversified supply base for influenza treatment and strengthening preparedness for future outbreaks and pandemics.
Fidson was selected alongside four manufacturers with global operations: Laurus Labs and MSN from India, and Desano and Guilin Pharma (Fosun) from China, as well as six regionally focused manufacturers: Biolab & Co. in Brazil, Kimia Farma in Indonesia, Hovid in Malaysia, QCIL in Uganda, Lekhim in Ukraine and Stellapharm in Vietnam.
The development follows the voluntary licence signed by MPP and Roche in May 2026. It marks the transition from the licensing agreement to the development and manufacturing phase, with selected manufacturers expected to work towards regulatory approval of quality-assured generic versions of the antiviral.
Under the agreement, manufacturers will have access to a technical data package, reference products for bioequivalence studies and other technical support intended to facilitate product development and regulatory approval.
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Charles Gore, executive director of the Medicines Patent Pool, said the implementation phase would allow manufacturers across multiple regions to begin work before another health emergency occurs.
“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,” Gore said.
According to him, MPP will work with the manufacturers on product development and regulatory approval, with the aim of making quality-assured generic baloxavir available as quickly as possible.
The selection of both global and regional manufacturers is designed to diversify supply pathways and bring production closer to the regions and populations that will need the medicine.
For Nigeria, Fidson’s selection gives the country a role in a global manufacturing network focused on influenza treatment and pandemic preparedness, while potentially expanding the pharmaceutical company’s participation in international health-product supply chains.
Biola Adebayo, managing director and CEO of Fidson Healthcare, said the selection validated the company’s focus on quality-assured pharmaceutical manufacturing and innovation.
“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 the company would contribute to efforts to strengthen regional health security and preparedness for future health emergencies.
“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,” he added.
The deal also comes as governments, pharmaceutical companies and international health organisations focus on lessons from recent health emergencies, particularly the vulnerability of global medicine supply chains when demand rises sharply during outbreaks.
Tamara Schudel, vice president and head of global policy at Roche, said the move from the initial agreement to sublicensing manufacturers demonstrated the potential of voluntary partnerships in pandemic preparedness.
She said the collaboration would help build “diverse, resilient supply pathways” to support faster responses to future health emergencies.
Aggrey Aluso, director for Africa at Resilience Action Network International, said regional manufacturing capacity would be important in ensuring that low- and middle-income countries have access to essential health products during future emergencies.
“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,” Aluso said.
Baloxavir marboxil is an antiviral medicine developed for the treatment of influenza. The Roche-MPP voluntary licence allows participating manufacturers to develop, manufacture and supply generic versions in 129 countries, subject to regulatory authorisation.
The open Expression of Interest process used to select the manufacturers was launched following the May 2026 licensing agreement. MPP assessed applicants based on criteria including technical and regulatory capacity and their commitment to developing and manufacturing quality-assured baloxavir products.
Fidson’s participation will therefore depend on successful product development and regulatory approval before generic baloxavir can be supplied in eligible markets.
For Nigeria’s pharmaceutical industry, the agreement also highlights the growing emphasis on local and regional manufacturing as part of broader efforts to reduce dependence on concentrated global supply chains.
Fidson said the partnership would support its contribution to broader access to the antiviral across eligible markets while strengthening the role of African manufacturers in the global health ecosystem.
