Samsung Bioepis to begin global phase-III trials for Avastin biosimilar

By Sohn Ji-young

Published : May 17, 2016 - 21:51

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Samsung Bioepis is scheduled to begin its final stage of clinical trials for SB8, its new biosimilar drug referencing Roche’s blockbuster cancer treatment Avastin (bevacizumab), around the world.

According to the EU Clinical Trials Register, Samsung Bioepis will carry out phase-III clinical trials for SB8 in 10 countries in Europe, as well as in Taiwan and Korea.

A total of 678 subjects are scheduled to participate, according to the EU database.

Samsung Bioepis headquarters in Songdo, Incheon (Samsung Bioepis)

Samsung Bioepis said the worldwide trials have yet to begin. It declined to comment on the exact starting date.

The upcoming trials are designed to compare the efficacy and safety of SB8 and Avastin among patients with metastatic or recurrent non-squamous non-small cell lung cancer, according to the EU database.

After the final trials conclude successfully, the company can submit the biosimilar drug for approval by drug regulators, drawing closer to commercialization.

In Korea, Samsung Bioepis has already received permission from the Ministry of Food and Drug Safety to begin carrying out the final stage of clinical trials for SB8.

By Sohn Ji-young (jys@heraldcorp.com)

Samsung Bioepis to begin global phase-III trials for Avastin biosimilar

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