Biosimilars patent litigation in the EU and the US: A comparative strategic overview

Abstract

Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed 'interchangeable' by regulatory bodies, such as the US Food and Drug Administration. Biosimilar patent litigation continues to evolve as biosimilars enter new global markets. This manuscript takes a look at patent litigation strategies in a more developed biosimilars market, the European Union (EU) and compares them to a developing biosimilars market, the US, where the litigation strategies are still unfolding. This manuscript is a first in a two-part series, which will later include patent litigation strategies in Canada and Japan, as well as updates in the EU and the US.