Biosimilars and Complex Generics Uptake Not as Expected – Why is that a Surprise?

Many articles had decried the fact that biosimilar uptake is not what FDA or the drug industry anticipated.  Look, I have been around in this industry in one form or another (pharmacist, regulator, and consultant) for 46 years and have seen a lot in my day.  They say history repeats itself – no I am not planning to go back to FDA – but the same concepts and forces are in play today as they were when Hatch-Waxman (H-W) was first passed.  What concepts and forces you may ask? The concept and force of fear and the unknown.  Let me explain.