FDA Approves First Biosimilar Etanercept

Sandoz's Erelzi (etanercept-szzs) approved to treat several inflammatory diseases

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(RxWiki News) The US Food and Drug Administration (FDA) has approved the first biosimilar etanercept

This medication can be found under the name Erelzi and is approved to treat multiple inflammatory diseases. These diseases include rheumatoid arthritis, moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in children, psoriatic arthritis, ankylosing spondylitis and moderate to severe plaque psoriasis. 

Erelzi (etanercept-szzs) is a recently approved biosimilar. A biosimilar product is a product that is highly similar to a biological product that has already been approved, according to the FDA. This product is known as a reference product.

Erelzi is available as an injection to be given under the skin. 

This medication treats inflammatory conditions by working on the immune system. But, because it works on the immune system, Erelzi may lower the ability of the immune system to fight infections.

In fact, this medication carries a boxed warning about the risk for serious infections. Your doctor will test you for tuberculosis before prescribing this medication and throughout treatment.

This medication also carries a warning about the risk for some types of cancer. There have been some cases of cancer in children and teenage patients who started on TNF-blocking agents like etanercept.

Commonly reported side effects of this medication include headache, injection-site reactions and sinus infections.

Erelzi is marketed by Sandoz, a division of Novartis.

Last Updated:
September 2, 2016