Biosimilars patent litigation in Canada and Japan: A comparative strategic overview and EU and US update

Abstract

Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed 'interchangeable' by medicines regulatory bodies, such as the US Food and Drug Administration. Biosimilar patent litigation continues to evolve as biosimilars enter new global markets. This manuscript is the second part of a manuscript that took a look at patent litigation strategies in a more developed biosimilars market, the European Union (EU), and compared them to a developing biosimilars market, the US, where the litigation strategies are still unfolding. This second part includes patent litigation strategies in two other developing biosimilars markets, Canada and Japan, as well as provides product and litigation updates in the EU and the US.