Fresenius Kabi: FDA Accepts BLA for Neulasta Biosimilar
May 27 2020 - 10:00AM
Dow Jones News
By Colin Kellaher
Fresenius Kabi on Wednesday said the U.S. Food and Drug
Administration accepted for review its biologics license
application for MSB11455, a biosimilar of Amgen Inc.'s cancer drug
Neulasta.
The Bad Homburg, Germany, healthcare company, a unit of
Fresenius SE, said the filing marks its first U.S. biosimilar
regulatory submission.
Biosimilars are near-copies of biologic drugs, such as Neulasta,
that are made from living cells and are analogous to generic copies
of traditional pill-form medicines.
The FDA has already approved three biosimilar competitors to
Neulasta, which is used to reduce the incidence of infection
associated with febrile neutropenia, a serious side effect of
chemotherapy.
Amgen in late April reported a 40% decline in first-quarter
Neulasta sales amid competition from the biosimilars.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 27, 2020 09:45 ET (13:45 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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