It costs about $1.2 billion to bring a single new drug to market in the U.S. today.[1] With a combination of high late-stage failure rates and the high cost of drug trials, the number of new drugs being approved by the FDA has flat-lined at historically low levels, falling from 53 in 1996 to just 19 in 2009.[2] If the cost of drug trials doesn’t come down, we will see far fewer new drugs on pharmacy shelves.

The purpose of this study was to apply net present value (NPV) modelling to evaluate the financial attractiveness and business risk of different categories of biosimilars. Challenges and opportunities of biosimilars are compared with those of standard small molecule generics. Minimum peak sales levels are required to create financial value were determined in order to derive recommendations for the selection of commercially rewarding biosimilar development candidates.