Fidson selected as regional sublicensee to expand access to influenza treatment and strengthen pandemic preparedness

Fidson Healthcare Plc, a prominent pharmaceutical manufacturer in Nigeria, has been chosen as a sublicensee to collaborate with Medicines Patent Pool (MPP) in developing and producing generic versions of baloxavir marboxil, an advanced antiviral medication for influenza. This decision comes as part of MPP's voluntary licensing agreement with Roche, which selects eleven manufacturers across nine countries to participate.

The sublicensee announcement follows a global gathering at the United Nations General Assembly in New York, where leaders discussed pandemic prevention, preparedness, and response. The event included a side discussion titled "Advancing pandemic preparedness through voluntary licensing, technology transfer, and local production," organized by MPP with support from Roche.

During this conversation, industry representatives, governments, and civil society members explored strategies to strengthen systems and partnerships ahead of the next health emergency.

Fidson Healthcare Plc's Managing Director and CEO, Biola Adebayo, expressed pride in being selected by the Medicines Patent Pool as a sublicensee under Roche's voluntary licensing program for baloxavir marboxil. She emphasized Fidson's dedication to quality-assured pharmaceutical manufacturing, innovation, and improving healthcare outcomes in Africa. Adebayo further highlighted the company's commitment to supporting global efforts in strengthening regional health security and ensuring access to life-saving medicines.

Charles Gore, Executive Director of the Medicines Patent Pool, commented on the sublicense agreements, stating that the focus now shifts to implementation with manufacturers from various regions. The company plans to work closely with these manufacturers to support product development and regulatory approval, with the ultimate goal of making quality-assured generic baloxavir accessible as soon as possible.

By merging global manufacturing capacity with regionally focused production, MPP aims to create a more geographically diverse and resilient supply base for the future.

Under the voluntary license, manufacturers like Fidson Healthcare Plc can develop, manufacture, and supply generic baloxavir marboxil to 129 countries, encompassing most low- and middle-income nations, pending regulatory approval. The agreement also offers manufacturers a technical data package, reference products for bioequivalence studies, and other resources to facilitate regulatory approval and speed up product availability.

The selection process involved an open Expression of Interest program, where MPP evaluated applicants based on technical and regulatory capabilities and their commitment to developing and manufacturing quality-assured baloxavir products. This combination of established and regionally focused manufacturers helps enhance supply resilience while building production capacity closer to affected regions and populations.