Data, Temporary Monopolies and Biosimilar Development

Biosimilars facilitate access to the lifesaving and life-changing effects of biologics through reduced prices. Against the increasing uptake of biosimilars in coming years it is important to consider some of the regulatory levers governments use to promote biosimilar uptake and use. Data exclusivity is one of these levers. This article shows that data exclusivity is essential to biosimilar development and therefore should be viewed as a right given to biosimilar manufacturers rather than as it is usually framed: a right given to originator biologic manufacturers. Without the benefit of data exclusivity biosimilars would be forced to complete full clinical trials on a pharmaceutical molecule that regulators have determined to be demonstrably similar to an already marketed pharmaceutical in terms of safety and efficacy. As well as exposing the biosimilar manufacturer to significant time delays and extra cost, this would raise serious moral and ethical questions with respect to duplication of clinical trials.