Nigerian drugmaker chosen to produce generic influenza antiviral
Fidson Healthcare has been selected as one of 11 manufacturers in nine countries to develop and produce a generic version of baloxavir marboxil, an influenza antiviral. The voluntary licence from Roche and the Medicines Patent Pool covers 129 countries, subject to regulatory approval, and includes technical support for product development.
Nigerian pharmaceutical company Fidson Healthcare Plc has been selected to develop and manufacture a generic version of baloxavir marboxil, an antiviral medicine used to treat influenza. Fidson is one of 11 manufacturers in nine countries chosen under a voluntary licensing agreement between Swiss pharmaceutical company Roche and the Medicines Patent Pool, a United Nations-backed public health organisation. The MPP announced the sublicences on September 25.
The manufacturers are based in Brazil, China, India, Indonesia, Malaysia, Nigeria, Uganda, Ukraine and Vietnam. The licence would allow them to develop, manufacture and supply generic baloxavir in 129 countries, subject to regulatory authorisation. The MPP said the agreement was intended to diversify supply routes for influenza treatment, support regional production and improve preparedness for future outbreaks and pandemics.
It said manufacturers in different regions could help build production capacity closer to the populations needing the medicines. Selected companies will receive access to technical data, reference products for bioequivalence studies and other support intended to assist product development and regulatory approval. The MPP said manufacturers were chosen after an open expression-of-interest process assessing their technical and regulatory capacity and commitment to quality-assured products.
Fidson’s managing director and chief executive, Biola Adebayo, described the selection as recognition of the company’s commitment to quality-assured manufacturing and innovation. He said the partnership would enable Fidson to support regional health security and preparedness for future emergencies. Charles Gore, the MPP’s executive director, said the organisation would work with the manufacturers on development and approval, with the aim of making quality-assured generic baloxavir available as quickly as possible.
The announcement came as global leaders discussed pandemic prevention and preparedness at the United Nations General Assembly.
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