Editor's Corner

A judge's decision that the FDA has to make up its mind on Sandoz's application for a biosimilar should, hopefully, force the agency into action and begin to clarify just how this market will develop. Sandoz has applied for marketing approval for a human growth hormone similar to one made by Pfizer. And the FDA, which has been dragging its feet on the subject, has been content to let it sit in limbo for more than two years. The FDA often hides behind inaction, a startlingly simple task for a large government bureaucracy. But the science behind human growth hormones is clear and a new generic niche in biosimilars is waiting to be born. There are compelling arguments to be made over the future of generics for complex biotech drugs. Human growth hormones, though, won't be part of that discussion. It's time for the FDA--which supposedly wants to speed up the whole approval process--to finally take the first step down what is likely to be a very long path. - John Carroll