Amgen Says FDA Approves Avsola for Same Indications as Remicade
December 06 2019 - 3:23PM
Dow Jones News
By Stephen Nakrosis
Amgen Inc. (AMGN) on Friday said the U.S. Food and Drug
Administration approved its Avsola for all approved indications of
Remicade.
Amgen said the indications include treatment of rheumatoid
arthritis, Crohn's Disease, ulcerative colitis and chronic severe
plaque psoriasis, among others.
The approval for Avsola, or infliximab-axxq, is the fourth from
the FDA for a product from Amgen's biosimilars portfolio, the
company said.
Avsola "was proven to be highly similar to Remicade with no
clinically meaningful differences," Amgen said.
Avsola is currently not available commercially.
Remicade is marketed by Janssen Biotech, Inc., a Johnson &
Johnson (JNJ) company.
--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
December 06, 2019 15:08 ET (20:08 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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