The FDA might be overprotecting biologics

If you invent a new pill and convince the FDA to approve it, you get a roughly seven-year monopoly on selling your drug. But if you develop a biologic, that period of exclusivity is 12 years. Among the reasons for the difference is the idea that inventing biologics is more time-consuming, but a new study suggests that’s not at all the case.

In a new Nature Biotechnology paper, a group of researchers looked at the 275 therapies approved between 2007 and 2016 and concluded that the median development time was 12 years, regardless of whether they were small-molecule drugs or biologics.

Further complicating matters is the fact that, as any pharma attorney can tell you, biologics almost never face competition once their statutory exclusivity expires. Humira, first approved in 2002, won’t face biosimilars in the U.S. until 2023. That, the authors say, is evidence the FDA should take a hard look at its exclusivity rules.