The Long and Winding Road To Biologic Follow-ons

A great unanswered question in biotechnology involves follow-on biologics. These products represent a challenge to brand-name biotech drugs similar to that posed by generics to traditional drugs, but with a key difference: follow-on biologics have scientific subtleties and complexities unforeseen in the 1980s, when chemical generics first gained approval by the U.S. Food and Drug Administration. While consumer groups and purchasers clamor for cheaper biopharmaceuticals, and biotech companies fiercely guard their hard-won expertise, patents, production processes, and clinical know-how, regulation remains unsettled. Laws governing follow-ons are changing, but not as fast as the science, which is as convoluted as a folded protein. Here's a look at where the law and science are today, and where they're heading.