Samsung Bioepis wins U.S. approval to sell cancer-treating biosimilar

By Lim Chang-won Posted : January 21, 2019, 10:02 Updated : April 3, 2019, 16:56

[Courtesy of Samsung Bioepis]

SEOUL -- Samsung Bioepis has won approval to sell Ontruzant, a cancer-treating biosimilar referencing Herceptin, in the United States. It was the company's first oncology biosimilar to receive approval from the U.S. Food and Drug Administration (FDA).

Samsung Bioepsis is a joint venture with Samsung BioLogics affiliated with South Korea's largest Samsung Group, and Biogen, U.S.-based pharmaceutical company Biogen. Bioepsis has been known for Imraldi, an adalimumab biosimilar referencing Humira.

Trastuzumab, sold under the brand name Herceptin, is a monoclonal antibody used to treat breast cancer developed by Swiss pharmaceutical giant Roche. Ontruzant will be distributed in the U.S. market by Merck, known as MSD, which sells the biosimilar in Europe.

"For many cancer patients in the U.S., battling cancer has not only been a health issue, but a considerable financial burden brought on by cancer treatment," Bioepis senior vice president Pak Sang-jin said in a statement. "We sincerely hope our trastuzumab biosimilar will do exactly that."

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