Amneal Gets FDA OK for Biosimilar to Amgen's Neulasta
May 27 2022 - 6:49AM
Dow Jones News
By Colin Kellaher
Amneal Pharmaceuticals Inc. on Friday said it received U.S. Food
and Drug Administration approval for Flynetra, a biosimilar to
Amgen Inc.'s cancer drug Neulasta.
The Bridgewater, N.J., pharmaceutical company said the approval
is its third this year for biosimilars used in oncology, adding
that it expects to launch the three products over the second half
of the year, along with a full patient support program.
Biosimilars are near-copies of biologic drugs, such as Neulasta,
that are made from living cells and are analogous to generic copies
of traditional medicines.
The FDA has already approved several biosimilar competitors to
Neulasta, which is used to reduce the incidence of infection
associated with febrile neutropenia, a serious side effect of
chemotherapy.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 27, 2022 06:34 ET (10:34 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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