The existence of what we now call “patent thickets” is a threat to the biosimilar industry (as well as to the introduction of affordable generic drugs). The possibility that innovator medications like AbbVie’s Humira (adalimumab) and Amgen’s Enbrel (etanercept) can retain market exclusivity decades beyond their original date of introduction angers all except the manufacturers’ shareholders.
Can use of the Medicare IPI achieve lower drug costs? The consensus is still out. However, it will almost certainly change the way biosimilar manufacturers will have to think about pricing their agents. And it could raise further questions about the wisdom of a biosimilar pipeline for some drug makers.
The implementation of the Biologics Price Competition and Innovation Act1 (BPCIA) raised a number of critical issues for manufacturers, payers, and prescribers. These include the big-picture questions of extrapolation of indications, interchangeability, and a radical new approach to evaluating the comparability of these drugs to their reference biologics, as well as approving them.