Federal health officials on Friday approved the first lower-cost copy of a biotech drug – a so-called “biosimilar” – in 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.
Neupogen, the trade name for filgrastim, is made by Amgen and was originally licensed in 1991.
Biotech drugs are powerful, injected medicines produced in living cells. They typically cost much more than traditional, chemical-based drugs.
“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
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.”
Noted the FDA: Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:
- patients with cancer receiving myelosuppressive chemotherapy;
- patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
- patients with cancer undergoing bone marrow transplantation;
- patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
- patients with severe chronic neutropenia.
Read the full FDA announcement at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm
