FDA Reviewing What Could Be First Biosimilar Drug
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.
Five years after Congress passed a law allowing 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, a big seller made by Amgen Inc. 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 in 10 months.