Model portefeuille
Rendement portefeulle
+12.035 %

Rendement AEX
+33.325 %

Startdatum
01-01-2009

Startwaarde portefeuille € 74082.37

Startwaarde AEX
€ 245.94


Laatste update:
29-01-2010

Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab

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Algemeen advies 05/05/2018 06:27
Holzkirchen, May 2, 2018 - Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab.

Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.

There is a substantial unmet need for access to safe and effective therapies. Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilar medicines. As the pioneer and global leader in biosimilar medicines, Sandoz has five biosimilar medicines currently marketed in various countries worldwide, as well as a leading global pipeline.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," etc. etc..

Sandoz is on Twitter. Sign up to follow @Sandoz_global at http://twitter.com/Sandoz_Global?.

Follow our blog at www.sandoz.com/makingaccesshappen?.

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