Biosimilars – an overview of the route to market in the US and Europe скачать в хорошем качестве

Biosimilars – an overview of the route to market in the US and Europe

Many of the top selling drugs worldwide are biologics and many companies are seeking to produce biosimilars to compete in these lucrative markets. Activity relating to biosimilars is intensifying in the US following the introduction of the BPCIA and continues in Europe since the first biosimilars were authorised in 2006. Successfully bringing a biosimilar to market raises different challenges to small molecule generics and there are differences in the approach in the US and Europe. In this webinar experts from Taylor Wessing and Willkie Farr discuss: The basics of the regulatory system in the US and Europe​ A history of approvals and launches in the US and Europe An overview of the “patent dance” under the BPCIA and contrast to the position in Europe