Many of the top-selling drugs worldwide are biologics, and several companies are seeking to produce biosimilars to compete in these lucrative markets. Activity relating to biosimilars has intensified in the US since the introduction of the BPCIA in 2009 and in Europe since the first biosimilars were authorised in 2006. Successfully bringing a biosimilar to market raises distinct challenges as compared to small molecule generics, and there are significant differences to understand between the approaches to US and European laws, regulations, and markets.
Session 1 of this series focusses on key factors decision makers need to be aware of when considering settlement, including:
- Recent biosimilars settlement agreements in the US and Europe
- Legal requirements driving settlement in Europe
- FTC scrutiny of biosimilars settlements in the US
