Biosimilars in Developed Economies: Overview, Status, and Regulatory Considerations

Biotherapeutics dominate the pipelines of pharmaceutical companies across the world today with products ranging from hormones, immune-modulators, monoclonal antibodies (mAbs), blood coagulation factors, enzymes and vaccines. However, they are considerably more expensive than their small molecule counterparts (pharmaceuticals) and as a result their contribution to the already unacceptably high healthcare costs in the developed economies (Europe, United States, Japan, Canada and South Korea) has been in the limelight in the last decade. This has resulted in the rise of biosimilars, seen as the affordable versions of innovator biotherapeutics. As the developed economies form the majority of the global sales of biotherapeutics, they are an attractive market for the biosimilars as well. Regulatory considerations for approval of biosimilars in these jurisdictions is likely to have a major impact on the adoption of biosimilars. In this paper, we offer a perspective on this topic while focusing on the developed markets. This article summarizes the main regulatory requirements for approval of biosimilars in Europe, United States, Japan, Canada, and South Korea. An overview on current biosimilars status and market in the aforesaid countries has also been included.