Sandoz US News


FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

Holzkirchen, Oct. 2, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel®* (etanercept) - a tumor necrosis factor alpha (TNF-α) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affecting approx. 1.3 million1 and 7.5 million2 people (respectively) in the US.

Sandoz launches ZarxioTM (filgrastim-sndz), the first biosimilar in the United States
• Launch follows March 6, 2015 FDA approval
• Sandoz One SourceTM offers patient support services

Holzkirchen, September 3, 2015 – Sandoz, a Novartis company, announced today that Zarxio™ (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar approved by the US Food and Drug Administration (FDA) and the first to launch in the US. introduction of rivastigmine transdermal system, an authorized generic version of EXELON® PATCH1, marketed by Novartis Pharmaceuticals Corporation.


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