FDA reviewing what could be first biosimilar drug

AP News
Posted: Jul 24, 2014 3:41 PM

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.

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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.