Amgen Says FDA Approves Avsola for Same Indications as Remicade

Date : 12/06/2019 @ 8:23PM
Source : Dow Jones News
Stock : Amgen Inc (AMGN)
Quote : 237.6  -3.89 (-1.61%) @ 4:59AM
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Amgen Says FDA Approves Avsola for Same Indications as Remicade

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   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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