Samsung Bioepis Eticovo’s (etanercept-ykro, biosmilar) Receives FDA’s Approval for All Eligible Indication

 Samsung Bioepis Eticovo’s (etanercept-ykro, biosmilar) Receives FDA’s Approval for All Eligible Indication

Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Accepted for Review by the US FDA

Shots:

  • The approval is based on a P-III study results assessing Eticovo vs the reference product (Enbrel) in 596 patients with rheumatoid arthritis across 70 sites in 10 countries
  • The study resulted in ACR20 (80.8% vs 81.5%) for 52 wks. confirming results of 24 wks. study in (78.1% vs 80.3%)
  • Eticovo (etanercept-ykro) is a biosimilar to Enbrel, a TNF blocker targeted for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis

Click here to read full press release/ article | Ref: Samsung Bioepis | Image: Bioworld

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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