Biosimilars Newsfeed
FDA Approval of a Biosimilar to Enbrel®
(FDA News Release, August 30, 2016)
On August 30, 2016, the US FDA approved etanercept-szzs (Erelzi) a biosimilar to Enbrel® (etanercept). Etanercept-szzs is approved as a biosimilar, but has not been designated an interchangeable product. Etanercept-szzs is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients ≥ 2 years, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis (all of the approved indications of the reference product).
The data supporting the approval of etanercept-szzs is summarized in the FDA Briefing Document, accessed here:
Web link
Reference
FDA News Release. FDA approves Erelzi, a biosimilar to Enbrel. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm. Accessed Aug 31, 2016.
