Innovation fuels the bio/pharmaceutical industry. With the Hatch-Waxman act of 1984, that created regulatory oversight of generic drugs and determined the period of exclusivity, branded pharmaceutical companies could no longer rest on their past successes. They must continually find new drugs to stay in business. With biosimilars on the way, protein-based drugs will no longer assure long term success for biopharmaceutical companies either. Relentless pursuit of innovation is what bio/pharmaceutical R&D is all about.

The reader will find the discussion continues in the following sections.