Fidson Healthcare Plc, a Nigerian drugmaker, has been chosen as one of 11 pharmaceutical manufacturers across nine countries to develop and manufacture generic versions of Roche's baloxavir marboxil. This selection is part of a voluntary licensing agreement with the Medicines Patent Pool, aimed at strengthening Nigeria's role in pandemic preparedness. The agreement will enable Fidson to produce and supply generic baloxavir marboxil in 129 countries, covering nearly all low- and middle-income countries, subject to regulatory authorization.
The selection was announced in New York on September 24, as global leaders gathered for the United Nations General Assembly. Fidson joins manufacturers in Brazil, China, India, Indonesia, Malaysia, Uganda, Ukraine, and Vietnam under sublicense agreements designed to broaden access to the influenza antiviral and build a more geographically diverse manufacturing base ahead of future health emergencies. Other manufacturers selected include Laurus Labs and MSN in India, Desano and Guilin Pharma in China, and regionally focused producers Biolab & Co. in Brazil, Kimia Farma in Indonesia, Hovid in Malaysia, QCIL in Uganda, Lekhim in Ukraine, and Stellapharm in Vietnam.
The sublicense agreements follow the voluntary license signed by MPP and Roche in May 2026 and are intended to move the agreement into implementation by supporting product development and regulatory approval. Under the license, manufacturers can develop, produce, and supply generic baloxavir marboxil, and will also receive technical data, reference products for bioequivalence studies, and expedited regulatory approval. This will enable the manufacturers to quickly make quality-assured generic baloxavir available.
Charles Gore, Executive Director of MPP, emphasized the importance of preparation before a health emergency occurs. He stated that the move reflected the preparation needed, saying, "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." The goal is to make quality-assured generic baloxavir available quickly.
Roche's Vice President and Head of Global Policy, Tamara Schudel, described the sublicensing agreements as an important milestone, saying voluntary partnerships can help create more resilient supply pathways. Aggrey Aluso, Director for Africa at Resilience Action Network International, noted that the initiative showed the importance of strengthening regional manufacturing so low- and middle-income countries are not left waiting for essential medicines.
Fidson Managing Director and Chief Executive Officer, Biola Adebayo, described the selection as an honor and validation of the company's commitment to quality pharmaceutical manufacturing and innovation. He stated that, "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."
The sublicensees were selected through an open Expression of Interest process based on technical and regulatory capacity and commitment to produce quality-assured baloxavir products. The model combines established manufacturing capability with regional production to build more resilient supply chains closer to intended populations. This partnership reinforces the growing role of African manufacturers in global health and strengthens Fidson's commitment to expanding access to quality-assured medicines across eligible markets.
Key points
- Fidson Healthcare Plc selected for global production of Roche influenza drug
- Agreement aims to strengthen Nigeria's role in pandemic preparedness
- Generic baloxavir marboxil to be produced and supplied in 129 countries
