Generics and Biosimilars Initiative (GaBI) Journal recently published an article by Brian Malkin, Senior Counsel, McGuireWoods LLP entitled: "Biosimilars patent litigation in the EU and the US: a comparative strategic overview."
The Abstract for the Review Article states:
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 (FDA). 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.
The mission of GaBI is to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care. GaBI aims to raise the scientific status of generic and biosimilar medicines, and to provide comprehensive, high quality, scientifically sound, reliable, well-documented and up-to-date information about generic and biosimilar medicines both in print and electronically in an open access format.
GaBI provides an umbrella for a range of activities, such as an online news exchange platform, an independent peer reviewed journal, educational workshops and scientific conferences. The multifaceted characteristic of GaBI and its involvement in the scientific world under various forms will ensure the wide dissemination of its objectives.
We will let you know when the companion article is published later.
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