FDA Says Rules to Copy Amgen Drugs Coming ‘Very Soon’

U.S. regulators plan to unveil rules for reviewing the first copies of biologic medicines “very soon,” according to Food and Drug Administration Commissioner Margaret Hamburg.

The health-care overhaul passed last year included a provision authorizing a process for approving cheaper copies of compounds made from living cells. The FDA is evaluating whether to require extensive clinical trials to judge whether the so-called biosimilars work as well as the products they copy. The outcome may differ from generic versions of common drugs now substituted at pharmacies to keep costs down.