Samsung Bioepis Announces Launch Of ONTRUZANT (trastuzumab) In Brazil For Early And Metastatic HER2-Overexpressing Breast Cancer

• ONTRUZANT (trastuzumab) is Samsung Bioepis’ first oncology treatment and second product to be launched in Brazil followed by BRENZYS, both in partnership with Bio-Manguinhos/Fiocruzⁱ and Bionovis
• Samsung Bioepis’ ONTRUZANT (trastuzumab) becomes the first HERCEPTIN biosimilar supplied to Brazil’s public health system, Sistema Único de Saúde (SUS), for early and metastatic HER2-overexpressing breast cancer

Samsung Bioepis Co., Ltd. today announced the launch of its first oncology treatment ONTRUZANT (trastuzumab), a biosimilar referencing HERCEPTIN^II , in Brazil. ONTRUZANT (150 mg single-dose vials) was approved by 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 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 United States (US), Ukraine and Korea. ONTRUZANT was first granted the European Commission (EC) Marketing Authorisation in November 2017 and approved by the US Food and Drug Administration (FDA) in January 2019.

“The launch of our first oncology treatment ONTRUZANT in Brazil is a step closer to realizing our mission which is to deliver high-quality, proven biologic medicines to more people,” said Josh Sang Hyun Lee, Vice President and Commercial Strategy Team Lead, Samsung Bioepis. “We are confident that ONTRUZANT will make a positive impact on breast cancer patients in Brazil as we remain committed to leveraging our strengths in product development and quality assurance.”

In Brazil, breast cancer is the most frequent cancer and the main cause of deaths among women. It is estimated that there are over 67,000 breast cancer patients which is growing by 2.54% every year.^{iii iv}

ONTRUZANT is being supplied to Sistema Único de Saúde (SUS), the country’s public health system, through a Productive Development Partnership (PDP) between Samsung Bioepis and local partners, Bionovis and Bio-Manguinhos.

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, visit www.samsungbioepis.com.

ⁱ Bio-Manguinhos is the Fiocruz unit responsible for technological development and the production of biopharmaceuticals, in addition to vaccines and reagents for diagnosis aimed primarily at meeting national public health demands
ⁱⁱ HERCEPTIN is a registered trademark of Genentech Inc.
ⁱⁱⁱ Gustavo Werutsky, Paulo Nunes, Carlos Barrios. Locally advanced breast cancer in Brazil: current status and future perspectives. eCancer. 2019, 13:895
^iv Instituto Nacional de Câncer. https://www.inca.gov.br/numeros-de-cancer