Impact of Ipsen’s court setback against FDA

Ipsen has lost its appeal after suing the US FDA for not classifying its cancer medication, Somatuline Depot, as a ‘biologic’ instead of a ‘drug’. This could have broader implications for the industry. Biologics enjoy longer sales exclusivity and generics must file an Abbreviated Biological License Application, making it harder for competitors to enter the market. Ipsen argued that despite not meeting FDA’s protein definition, the end drug’s size exceeded 40 amino acids. The court disagreed.