Posted by Michael Wonder on 12 Dec 2018
FDA takes aim at pharma’s biosimilar-delaying tactics
12 December 2018 - Ever-rising cost of insulins also to be targeted.
FDA Commissioner Scott Gottlieb has repeated a warning that the agency will crack down on delaying tactics deployed by pharma to block cheaper biosimilar alternatives.
In a statement yesterday, Gottlieb highlighted one example of that activity, which is companies “using – and sometimes abusing – limited distribution systems” such as those deployed in Risk Evaluation and Mitigation Strategy programmes.
