The agreement will allow Samsung Bioepis to distribute, market and sell the biosimilar Ontruzant in the United States, according to the source.
Ontruzant, the breast cancer treatment biosimilar referencing Roche's Herceptin, won approval from the U.S. Food and Drug Administration earlier this year.
Samsung Bioepis is a joint venture between Samsung BioLogics -- a biopharmaceutical unit of South Korea's top conglomerate Samsung Group -- and its U.S. partner Biogen Inc.
Biosimilars are defined by the FDA as products that are "highly similar to an already approved biological product" and have "no clinically meaningful differences in terms of safety and effectiveness from the reference product." (Yonhap)
|Headquarters building of Samsung Bioepis Co.in Songdo, west of Seoul.|
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