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Official Answer by 30 Nov 2016

Sandoz's Erelzi (etanercept-szzs) is a biosimilar for the reference product Enbrel (etanercept) approved in August 2016. Erelzi is the first approved biosimilar for etanercept, and the third biosimilar available on the US market.

A biosimilar is a biological product that is “highly similar” to a U.S.-licensed reference biological (in this case Enbrel). The FDA has determined there are no clinically meaningful differences between the biological product Erelzi and the original reference product Enbrel in terms of safety, purity, and potency. However, a biosimilar is not considered a “generic” in the same way that a traditional drug is determined to be a generic.

Erelzi is used for the same five indications found on Enbrel product labeling:
- rheumatoid arthritis,
- polyarticular juvenile idiopathic arthritis,
- psoriatic arthritis,
- ankylosing spondylitis, and
- plaque psoriasis.

It’s important to note that Erelzi is not an interchangeable product with Enbrel at the pharmacy level. Physicians must write the prescription specifically for Erelzi, as pharmacists cannot automatically substitute Erelzi for Enbrel.

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