Deals on generic versions of Roche flu drug aimed at preparing for pandemic

Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.

With an eye toward pandemic preparedness, a U.N.-backed agency has signed sub-licensing deals with 11 manufacturers to develop and manufacture generic versions of a Roche influenza treatment.

Under the agreements, brokered by the Medicines Patent Pool, the companies can develop, manufacture, and supply Xofluza in 129 countries, covering nearly all low- and middle-income nations. The manufacturers will also have access to technical data, reference products for bioequivalence studies, and other support intended to help with regulatory approval in those countries.

This marks the latest effort to widen access for a needed medication to lower-income countries, a goal that has often required the pharmaceutical industry to balance its financial priorities with ensuring its medicines can be affordably obtained by the largest number of patients possible.