WASHINGTON, D.C. (AP) — The Food and Drug Administration is reviewing research data on what could become the first U.S.-approved "biosimilar" drug, a cheaper, sort-of generic version of a biologic drug.
Nearly five years after Congress passed a law enabling future approval of biosimilars, for the first time the FDA has accepted an application to sell a similar, but not identical, version of a biologic drug.
The FDA is evaluating Swiss drugmaker Novartis AG's application to sell a biosimilar version of Neupogen, which brought maker Amgen Inc. $1.4 billion in sales last year. Neupogen, known chemically as filgrastim, treats a dangerous decrease in infection-fighting white blood cells, common in cancer patients getting certain treatments.
Sandoz, the generic division of Novartis, already sells three biosimilar drugs, including filgrastim, in about 60 other countries.
The FDA should make its decision after a standard 10-month review, a spokeswoman said.
"Biosimilars have been successfully used in Europe and other markets for years," Ralph Neas, CEO of the Generic Pharmaceutical Association, said in a statement. "Filgrastim's filing acceptance moves us closer to the day when U.S. patients that currently must rely on costly brand biologics for treatment will have more choices."
Biologic drugs are powerful, injected medicines produced in living cells. They are much more expensive to produce than traditional pills made by mixing chemicals. Some newer ones cost more than $100,000 per treatment course, making copayments unaffordable for many patients.
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