Stock Watch: Class Of 2016 FDA Approvals

In 2017, while working in a drug pricing and commercialization consultancy, I prepared a slide analyzing the 2016 sales of the 35 novel drugs that were approved in 2011. I have just repeated the exercise for the drugs approved in 2016. Five years may not always be enough to reach blockbuster status, but among the 22 drugs that were approved by the US FDA in 2016, five blockbusters had stretched away from eight with undisclosed or absent sales by 2020. And then there were those in between.

To demonstrate to smaller biotechnology companies the importance of conducting market research with payers, the slide I constructed in 2017 showed that 19% of drugs approved by the US FDA in 2011 had annual sales of less than $20m five years after approval. Those products were abject commercial failures. As my argument went at the time, it would have been better to find out they were likely to yield permanent losses before the significant investments in Phase III and launch activities were made. In Europe, the situation was worse, with 46% of drugs approved there in 2011 having sales below $20m in 2016. A 2001 Nature Biotechnology