Biosimilars are biologic medicines that are similar to currently available biologic therapies known as originators. These complex large molecule drugs are considered as the next wave in medicine, promising new treatments to help more patients with serious and complex diseases. Now that patents covering some of these medicines have expired or are approaching expiry, regulators across the world have created new incentives for biologic drug development and new procedures to allow for similar versions — biosimilars — of originator biologics to enter the market.

While regulatory pathways for the market approval of these drugs have been available in both Europe and in the US for a couple of years, the nature of biosimilars creates many regulatory and definitional challenges and complexities. Moreover, there are an increasing number of new biologics and biosimilar applications on the horizon that give rise to additional questions.

Many of the unsolved issues are comparable in Europe and the US, but they will often need to be addressed within different legal settings. The US Supreme Court, for example, recently decided on crucial questions concerning the so-called biosimilar "patent dance", and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product. It can can be assumed that the forthcoming decision will have broad ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

At this panel debate, European, US and South-American scientific and legal experts discuss the implications of these developments both from a regulatory and intellectual property law perspective.