NVS Novartis AG

   By Donato Paolo Mancini 
 

Novartis (NOVN.EB) said late Wednesday that the U.S. Food and Drug Administration had turned down its subsidiary Sandoz's rituximab biosimilar application.

The company said that biosimilars division Sandoz received a complete response letter from the FDA--the document the U.S. agency issues when it denies an application.

Rituximab is a cancer drug whose European and U.S. patents expired in 2013 and 2016 respectively. Biosimilars are medical formulations with properties similar to drugs that have already been licensed.

Novartis said Sandoz remains committed to further discussions with the FDA in order to bring the biosimilar to U.S. patients as soon as possible. It said it stands behind the body of evidence included in the regulatory submission and that it is evaluating the contents of the FDA's letter.

Sandoz currently markets five biosimilars worldwide.

Write to Donato Paolo Mancini at donatopaolo.mancini@dowjones.com

(END) Dow Jones Newswires

May 03, 2018 02:50 ET (06:50 GMT)

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