Judge pushes FDA on biosimilar decision

A federal judge has ruled that the FDA has to issue a decision on Sandoz's application to market a version of a human growth hormone, adding new pressure on the agency to decide how to handle applications for generic biologics. Sandoz wants to manufacture a biosimilar to a product made by Pfizer, but the FDA has failed to offer its judgment. The FDA has said for several years now that it wants to outline guidelines for biosimilars but has failed to deliver. Some analysts speculate that the judge's ruling may push the agency to deliver this time.

- read the report from The Wall Street Journal (sub. req.)