The problem with biologics - and why biosimilars are not the answer

Due to a unique interplay of patent protection, regulatory exclusivity and trade secrets, the biopharmaceutical industry has so far been shielded from substantial generic competition. The introduction of biosimilars onto the market has not resulted in significant price reductions, and concerns regarding the substitution and interchangeability of original biologics with biosimilars persist.

This seminar will discuss how the biologics production process distorts the trade-offs that traditionally guided both patent protection and regulatory exclusivities: disclosure as key condition for benefiting from the corresponding monopoly position.