ABSTRACT

Biosimilars have gradually entered the global pharmaceutical market place. The first biosimilars, somatropin and epoetin alfa, were launched in 2006 and 2007 respectively in Europe. The US saw biosimilars only a decade later with the launch of filgrastim biosimilars in 2015. In contrast to generics, which mainly must show bioequivalence for approval, biosimilars are required to demonstrate similarity to the originator in both non-clinical and clinical testing. Most healthcare systems don’t give any specific financial incentives to prescribe biosimilars. Reimbursement rates are typically the same between brand and biosimilar. Particularly regional and local payers use tender mechanisms to drive down cost for generics and biosimilars. China and India have seen rapid uptake of biosimilars as a result of lower regulatory barriers and high cost sensitivity. Norway’s tender structure has resulted in steep cost reductions and high uptake.