Samsung Bioepis launches Ontruzant in Brazil

Samsung Bioepis today announced the launch of its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Roche’s (ROG: SIX) Herceptin, in Brazil.

Ontruzant (150mg single-dose vials) was approved by the Agência Nacional de Vigilância Sanitária (ANVISA), the country’s health regulatory agency for the treatment of metastatic HER2-overexpressing breast cancer, early HER2-overexpressing breast cancer, and advanced gastric cancer.

Samsung Bioepis, a joint venture between South Korea’s Samsung BioLogics and US biotech major Biogen (Nasdaq: BIIB), obtained Marketing Authorization for Ontruzant in Brazil in May 20, 2019. With the Brazil launch, Ontruzant is now available in six markets: Brazil, Australia, Europe, the USA, Ukraine and South Korea. Ontruzant was first granted European Commission (EC) Marketing Authorization in November 2017 and was approved by the US Food and Drug Administration (FDA) in January 2019.