Blinded by (a Lack of Science: LImitations in Determining Therapeutic Equivalence of Follow-On Biologics and Barriers to Their Approval and Commercialization

Over the past twenty years, an increasing number of disease therapies based on recombinant DNA technology have been developed and commercialized. These treatments, commonly known as biologics, can be very effective. They can also be extraordinarily expensive. In an effort to ensure the availability and affordability of biologics, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010. The BPCIA was designed to facilitate the approval of generic versions of biologics, striking a balance between facilitating the approval of generic biologics with a new regulatory pathway and protecting innovation of new biologics by offering a period of regulatory exclusivity much as the Hatch-Waxman Act (HWA) had done for small-molecule drugs. This Article takes the position that because of differences between the composition and features of small molecule drugs and biologics, as well as between the abbreviated-approval pathways instituted by the BPCIA and the HWA, pioneer and generic manufacturers seeking to market biologics will face distinct regulatory and patent litigation considerations compared with small-molecule drugs. First, it considers the important technical differences between small-molecule drugs and biologics and how these differences are likely to be reflected in different regulatory approaches under the HWA and BPCIA abbreviated-approval pathways. Second, the Article considers the particular role that production methods play in determining the characteristics of biologics. The complexity of these production methods can make it difficult to adjudge the presence of therapeutic equivalence between pioneer and generic biologics because it is difficult to ensure that production methods used by different manufacturers are identical. Method patents will also be litigated in distinct ways under the HWA and the BPCIA. Third, the Article argues that, as currently structured, the BPCIA is not likely to result in the dramatic reductions in healthcare costs that some of its proponents expect. This will be because of both difficulties in guaranteeing equivalence between pioneer and generic biologics and the strong protection offered to pioneer biologics manufacturers by process patents. The best way to ensure that the introduction of generic biologics can help meet the price reduction goals of the BPCIA is to work toward improvements in technical and regulatory procedures for determining equivalence between pioneer and generic biologics