> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Sandoz Biosimilar for Enbrel Copy
- URL: https://www.fdaweb.com/fda-approves-sandoz-biosimilar-for-enbrel-copy/
- Published: 2016-08-30T12:00:00.000Z
- Updated: 2026-09-14T21:27:44.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136659

FDA has approved a Sandoz BLA for Erelzi, (etanercept-szzs) a biosimilar copy of Amgen’s Enbrel (etanercept), indicated for treating rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. Last month, the agency’s Arthritis Drugs Advisory Committee voted 20 to 0 to support the product’s approval ([see earlier story](https://www.fdaweb.com/advisory-committee-backs-sandoz-enbrel-biosimilar/)).

“The FDA’s approval of Erelzi is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Erelzi is biosimilar to Enbrel,” an agency [release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm?ref=fdaweb.com) says. The product was not approved as an [interchangeable](http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm241718.htm?ref=fdaweb.com) product, it adds.