A Biosimilar Version of Enbrel Gains FDA Approval

By Spondylitis Association of America

Monday, September 12, 2016

The Food and Drug Administration (FDA) approved the biologic Erelzi (etanercept-szzs) in late August for conditions including ankylosing spondylitis and psoriatic arthritis. Erelzi is a biosimilar version of the long-used tumor necrosis factor (TNF) inhibitor Enbrel (etanercept).

According to the FDA news release on Erelzi’s approval, “Biological products are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness from the reference product, in addition to meeting other criteria specified by law."

It is important to note that Erelzi has been approved as a biosimilar only; the FDA has not approved the medication as being interchangeable with Enbrel.

Erelzi is currently approved for the following conditions:

  • moderate to severe rheumatoid arthritis;
  • moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
  • active psoriatic arthritis, including use in combination with Methotrexate (MTX) in psoriatic arthritis patients who do not respond adequately to MTX alone;
  • active ankylosing spondylitis; and 
  • chronic moderate to severe plaque psoriasis in adults.

Erelzi is the second biosimilar medication to gain FDA approval for forms of spondyloarthritis. Inflectra, a biosimilar version of Remicade (infliximab) was approved in April of this year for ankylosing spondylitis, psoriatic arthritis, and others.

Similarly, a third biosimilar medication, currently referred to as ABP 501 is being investigated for approval. The FDA Arthritis Advisory Committee has recommended approval of Amgen’s ABP 501, which is a biosimilar version AbbVie’s Humira (adalimumab) in July of this this year. However, even if approved by the FDA, Amgen may be stopped from launching the biosimilar anytime in the near future, as AbbVie claims that Humira’ s U.S. market exclusivity will remain valid until 2022 due to the complex newer patents secured by the pharmaceutical company. AbbVie filed a patent-infringement suit against Amgen in August.

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