Biosimilars – Clearing the way for launch

In the third webinar of our series exploring the key differences between US and Europe biosimilars litigation and regulation, our experts discuss strategies for clearing the way to an early launch of a biosimilar.

Many of the top-selling drugs worldwide are biologics, and several companies are seeking to produce biosimilars to compete in these lucrative markets.

There are an increasing number of biologics reaching the end of their primary patent protection, and these companies must navigate the landscape of secondary patent protection in order to launch their biosimilars.

The strategies for doing so differ in the US and Europe, and there are different tools available.

Session 3 of this series focuses on strategic options for securing an early launch of a biosimilar, in particular:

• devising a strategy to clear the way in Europe
• so-called Arrow declarations may be available to provide a defence to any pending patent applications
• Devising a strategy to clear the way in the US.