|Samsung Bioepis headquarters in Songdo, Incheon.|
Samsung Bioepis said that the U.S. Food and Drug Administration (FDA) has accepted the company's biologics license application for SB8, a biosimilar candidate, an Avastin biosimilar.
The company submitted its BLA to the FDA in September this year.
Avastin, the original drug, 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 won), of which U.S. market sales accounted for 42 percent with 2.9 billion Swiss francs (3.5 trillion won).
SB8 is the fifth biosimilar and the anticancer treatment that Samsung Bioepis has brought to the global market. Samsung Bioepis is also undergoing an approval process for the drug in Europe after submitting a European marketing license application in July. The company is the first local company to undergo an approval process for an Avastin biosimilar.
The FDA's acceptance of the Samsung Bioepis’ application comes after the company presented the results of phase 3 study clinical evaluating the efficacy and safety of SB8 at the European Society for Medical Oncology (ESMO) 2019.
The research compared SB8 to the original in 763 patients with metastatic or recurrent non-squamous NSCLC, and the company demonstrated equivalence in terms of the ratio of patient risk response to the original drug.
"We will demonstrate our R&D ability through the U.S. marketing authorization review process for SB8 and make efforts to secure various product portfolios in the future," a company official said.
If SB8 is approved, it will mark the company's fifth biosimilar to enter into the U.S. As of now, the company has received approvals for Renflexis (Original: Remicade), Eticovo (Original: Enbrel), Hadlima (Original: Humira) and Ontruzant (Original: Herceptin) in the U.S.
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