FDA approves etanercept biosimilar

medwireNews: The US FDA has approved etanercept-ykro for the treatment of various rheumatic diseases.

This approval was based on data demonstrating that the biosimilar has no clinically meaningful differences in safety and efficacy profiles to the etanercept reference product.

Etanercept-ykro is approved for the same indications as the originator, namely rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis in patients aged 2 years or older, and plaque psoriasis in those aged 4 years or older.

The tumor necrosis factor inhibitor is administered by subcutaneous injection, and carries a boxed warning for serious infection and malignancy risk.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

See also:

• International recommendations for the use of biosimilars issued
• Equivalence of GP2015, etanercept demonstrated
• Etanercept biosimilar shows potential for the treatment of RA
• No worsening in disease activity with switch to biosimilar etanercept