FDA approves Sandoz Erelzi(TM) to treat multiple inflammatory diseases - Seite 2

An application for Sandoz biosimilar etanercept has been accepted by the European Medicines Agency (Q4 2015) and is currently undergoing review.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. Sandoz is the pioneer and global leader in biosimilars and currently markets three biosimilars.

Sandoz has a leading biosimilar pipeline and plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. This will be enabled by 11 filings over a three-year period (2015-2017), with six already submitted. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ERELZI(TM)?
ERELZI is a medicine that affects your immune system. ERELZI can lower the ability of your immune system to fight infections. Serious infections have happened in patients taking ERELZI. These infections include tuberculosis (TB) and infections caused by viruses, bacteria or other opportunistic pathogens that have spread throughout the body. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Some patients have died from these infections. Your doctor should test you for TB before you take ERELZI and monitor you closely for TB before, during, and after ERELZI treatment, even if you have tested negative for TB. Treatment with ERELZI should not be initiated in patients with an active infection, including clinically important localized infections. Patients have frequently presented with disseminated rather than localized disease. There have been some cases of unusual cancers reported in children and teenage patients who started using tumor necrosis factor (TNF) blockers before 18 years of age. Also, for children, teenagers, and adults taking TNF blockers, including ERELZI, the chances of getting lymphoma, leukemia, melanoma, non-melanoma skin cancer or other cancers may increase. Patients with RA or psoriasis may be more likely to get lymphoma.