WASHINGTON – 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.
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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."