Sandoz US News
• Erelzi is the first biosimilar etanercept approved by the FDA, offering expanded access to this important medicine • Erelzi is approved for all indications included in the reference product’s label • Erelzi is the second biosimilar from Sandoz to receive FDA approval in the US, building upon established global leadership in biosimilars
Princeton, New Jersey, July 21, 2016– Sandoz today announced the U.S. market introduction of rosuvastatin calcium tablets, a generic version of Crestor® by AstraZeneca Pharmaceuticals LP 1.
Holzkirchen, 13 July, 2016. Sandoz, a Novartis division and leader in biosimilars, announced today that the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of its proposed biosimilar etanercept. The committee voted unanimously (20-0), in support of biosimilar etanercept for all five indications of the reference product, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic psoriasis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA).
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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.