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)

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