In March 2015, the US Food and Drug Administration (FDA) approved the first biosimilar in the United States, ushering in the age of biosimilar competition for biologics. A biosimilar is defined by the FDA as “[a] product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” The FDA requires that a biosimilar product deliver the same dosage and strength as the reference product and be used for the same indications as the reference product. The approval of biosimilars was authorized by the Biologic Price Competition and Innovation Act (BPCIA), which is part of the Affordable Care Act. It allows biosimilar manufacturers to file an abbreviated application using the original producer’s data, provided that this producer has had at least 12 years of data exclusivity. The first approved biosimilar was the recombinant colony-stimulating factor filgrastim-sndz, made by Sandoz/Novartis, which is the biosimilar version of filgrastim, marketed by Amgen as Neupogen. Apotex has 2 biosimilar applications currently under active review by the FDA for filgrastim and pegfilgrastim, a biosimilar of Amgen’s Neulasta, a long-acting form of Neupogen. Celltrion has a biosimilar application under review for infliximab, marketed by Janssen Biotech as Remicade. More approvals are expected because a patent cliff for biologics is imminent in the United States, with an estimated $100 billion worth of biologics set to lose patent exclusivity by 2020. The eFigure in the Supplement presents a sample of the trends in loss of patent exclusivity. These developments may suggest that biosimilars may have the potential to be the equivalent of generic drugs, which generated an estimated 80% to 90% cost savings for patients. In this Viewpoint, we explain why biosimilars are unlikely to deliver such benefits and discuss ways in which public policy might increase the competitive benefits of biosimilars.
Chandra, Amitabh, and Jacqueline Vanderpuye-Orgle. "Competition in the Age of Biosimilars." Journal of the American Medical Association 314.3 (July 2015).