FDA Approves Biosimilar for Various Inflammatory Diseases

The FDA has approved Erelzi (etanercept-szzs) for the treatment of multiple inflammatory diseases, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Erelzi is a biosimilar to Enbrel (etanercept), which was originally approved in 1998.
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The approval of Erelzi is based upon 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 demonstrating Erelzi is biosimilar to Enbrel.

The most serious side effects of Erelzi include infections, neurologic events, congestive heart failure, and hematologic events. Common adverse events include infections and injection site reactions.

—Michael Potts

Reference:

FDA. FDA approves Erelzi, a biosimilar to Enbrel [press release]. August 30, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm.