Emerging markets represent the lion's share of the global economy. At the same time, many of these emerging markets face grave, complex health crises. Pharmaceutical litigation will thus likely increase, both in the established markets like the United States and emerging markets like South Africa. This article offers guidance to those preparing to litigate biosimilar-related cases in both contexts, and draws lessons from each that may inform the other.
Biosimilar Regulatory Framework in the United States and South Africa
A biosimilar is a biologic medical product that is similar to, but not an exact copy of, a medical product that is manufactured by a different company. Worldwide, many nations have implemented regulations governing the development of biosimilar pharmaceuticals in the last decade. See Anita Krishnan et al., "Global Regulatory Landscape of Biosimilars: Emerging and Established Market Perspectives," 5 Biosimilars 19, 23 (2015). The European Union (EU) led the charge, and their regulations have become the foundation for many of the biosimilar regulations found around the world today. The United States' five-year-old emerging regulatory framework is the product of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) that was passed as part of the Affordable Care Act. See 42 U.S.C. § 262(k). South Africa, on the other hand, developed its regulatory framework earlier, but more heavily based it on the EU model. See Krishnan, supra, at 24.