Biosimilar Approvals and the BPCIA: Too Soon to Give Up

Critics who compare biosimilar approval numbers unfavorably to the Hatch-Waxman Act’s success with generics overlook key structural differences that explain the slower pace of biosimilar market entry. US biosimilar approvals have actually outpaced the EU’s during comparable post-enactment periods, and an upward trend in approvals, promising price discounts abroad, and a robust development pipeline suggest the BPCIA framework should be refined rather than abandoned.