Unlike drugs which are synthesized chemically, some of the most amazing drugs developed in recent years are actually synthesized biologically, the so-called biologics. I’ll leave it as an exercise for the reader to learn about some of these are made, but it’s a rather involved process. The differences between the synthesis of large molecule biologics and standard pharmaceuticals are profound and have led to a complicated state of affairs for entrance into their market by generics. Here are a couple of resources I found today addressing some of these issues. One of them is a speech delivered by the former head of the FTC and the other is a paper by several gentleman from Duke University.
Anyone have thoughts on this?