Sandoz US News
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.
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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Sandoz is a world leader in generic pharmaceuticals, providing access to a wide array of high-quality, affordable medicines. In the US, Sandoz markets more than 200 different generic drugs, including enoxaparin sodium injection, the first generic version of Lovenox®, and Omnitrope®, the groundbreaking follow-on biologic. Our 2,300 US associates are proud to make Sandoz a "healthy decision."
As part of the Novartis group, we believe that superior quality is the key to our long-term success. Our state-of-the-art technologies, decades of experience, and rigorous across-the-board quality standards all contribute to our broad portfolio of premium quality generic medicines.
We use innovation and expertise to go beyond standard generics and develop even the most complex medicines, which add value to patient healthcare – from generic injectables and ophthalmics to biosimilars and respiratory. Driving patient access to cost-effective treatment is how we are shaping the future of healthcare.
Sandoz was the first company to develop and market follow-on versions of highly-complex biopharmaceuticals. Today, we are the undisputed global leader in this segment and have an industry-leading pipeline that will make essential biologics more affordable for all.