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  • FDA Initiates biologics license of SB8, Samsung Bioepis
  • by Chon, Seung-Hyun | translator Choi HeeYoung | Nov 22, 2019 06:32am
Submitted BLA of SB8, the fifth biosimilar that Samsung Bioepis has brought to US market
Samsung Bioepis announced on the 20th that FDA has initiated the approval and evaluation of the 'SB8' biosimilar of Avastin.

In September, the FDA completed BLA for approval and entered into full-scale review for product approval

Avastin, the original drug in Roche, has indications for metastatic colorectal cancer and non-small cell lung cancer (NSCLC). As of 2018, Avastin's annual global sales amounted to a total of 6.8 billion Swiss francs (₩ 8.2 trillion), of which U.S. market sales accounted for 42% with 2.9 billion Swiss francs (3.5 trillion won).

In the US, the Avastin biosimilar market has already occupied by Amgen and Pfizer. Amgen released a biosimilar in July without Avastin's patent agreement,
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