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AUGUST 31, 2016

FDA Approves Erelzi, a Biosimilar to Enbrel

By PPN News Staff

The FDA approved etanercept-szzs (Erelzi, Sandoz) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept, Amgen), which was originally licensed in 1998.

Administered by injection, Erelzi received approval for all the indications of the reference product:

  • moderate to severe rheumatoid arthritis, either as a stand-alone therapy or in combination with methotrexate (MTX);
  • moderate to severe polyarticular juvenile idiopathic arthritis in patients 2 years of