UPDATE : Monday, June 1, 2020
FDA OKs Samsung Bioepis’ Etanercept biosimilar
  • By Lee Han-soo
  • Published 2019.04.26 14:22
  • Updated 2019.04.26 15:09
  • comments 0

Samsung Bioepis has received sales approval for Eticovo (Original: Enbrel), an Etanercept biosimilar, from the U.S. Food and Drug Administration.

Samsung Bioepis headquarters in Songdo, Incheon.

Enbrel is one of the most purchased drugs worldwide with an estimated $8.87 billion in sales in 2016. It has applications for autoimmune diseases, including rheumatoid arthritis, psoriasis, and other inflammatory conditions. With the approval of the biosimilar, also known as Benepali in EU, the company now has three biosimilars – Eticovo, Renflexis and Ontruzant -- approved in the U.S.

Eticovo has emerged as the flagship product of Samsung Bioepis in EU as it has surpassed 1 trillion won ($863.7 million) in cumulative sales in three years of its launch.

“With the third biosimilars approved in the U.S., the company has once again demonstrated its global R&D capability,” Samsung Bioepis CEO Ko Han-sung said. “We will continue to work to ensure that more patients have the opportunity to use high-quality biopharmaceuticals at a reasonable price.”


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