FDA: Generic Biotech Drugs Require Paradigm Shift, Gives Glimpse of Biosimilar Approval Process

Evaluating generic versions of complex biotechnology medicines will require a new, more rigorous review process, U.S. drug regulators said, in the first glimpse of their thinking on the subject. Drugmakers, investors and others have been clamoring for more insight into the approval process for cheaper versions of biotech drugs, known as "biosimilars" -- a potentially multibillion dollar market. In an article in this week's New England Journal of Medicine made public on Wednesday, officials from the U.S. Food and Drug Administration said the approval for biosimilars "will require a new paradigm of sponsor-FDA interactions," involving analysis of much more data than traditional generics.