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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze