Federal health officials say they approved the first lower-cost copy of a biotech drug, a long-awaited milestone that could generate billions in savings for insurers, doctors and patients.
The Food and Drug Administration says it approved Novartis' version of the blockbuster drug Neupogen, which is used to boost blood cells in cancer patients and had $839 million in U.S. sales last year.
Biotech drugs are powerful, injected medicines produced in living cells. They typically cost much more than traditional, chemical-based drugs.
Biotech drugs have never faced generic competition in the United States because the FDA did not have a system to approve copies of such medications. That changed in 2012 when the FDA laid out a regulatory pathway to approve the drugs, known as "biosimilars."