It is expected that Samsung Bioepis will soon be able to obtain permission to sell its new biosimilar products in the global market.
According to Samsung Bioepis on June 28, it has obtained a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Avastin (AVASTIN®) biosimilar AYBINTIO® project named SB8.
It received positive opinion from the advisory committee about 11 months after the EMA began its review of the sales permit in July last year, and it is expected to obtain official sales approval after a final review by the European Commission, which usually takes two to three months.
AYBINTIO's original drug Avastin is a tumor disease treatment sold by Roche, Switzerland, and has indications of metastatic colorectal cancer, non-small cell lung cancer and metastatic breast cancer in Europe.
Avastin's global sales totaled 7.073 billion (about 8.5 trillion won) Swiss francs last year. Of the total, sales in the European market amounted to 1.794 billion Swiss francs (2.2 trillion won or $1.8 billion), accounting for a quarter.
"We once again proved Samsung Bioepis' R&D capabilities in the global market," said Ko Han-seung, CEO of Samsung Bioepis. "We have opened the possibility of further expanding the treatment benefits of cancer patients through high-quality biopharmaceuticals."
