●150 mg and 420 mg vial of ONTRUZANT® are now approved
INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved a 420 mg multi-dose vial of ONTRUZANT® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN® i (trastuzumab).
ONTRUZANT® was first approved as a 150 mg single-dose vial by FDA in January 2019 across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease. Please see Boxed Warnings and Important Safety Information for ONTRUZANT® below.
ONTRUZANT® will be marketed and distributed in the United States (US) by Merck (known as MSD outside the US and Canada), which announced on February 5, 2020, that it intends to spin-off products from its biosimilars businesses, including ONTRUZANT®, into a new, independent, publicly-traded company. Merck will continue to fully support the commercialization of ONTRUZANT® until the spinoff, which is intended to take place in the first half of 2021, at which time ONTRUZANT® will become a product of the new company.
About ONTRUZANT® (trastuzumab-dttb)
ONTRUZANT® is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
ONTRUZANT® is indicated:
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
ONTRUZANT® is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
Select Important Safety Information
Cardiomyopathy
Infusion Reactions; Pulmonary Toxicity
Embryo-Fetal Toxicity
Exacerbation of Chemotherapy-Induced Neutropenia
Most Common Adverse Reactions
These are not all of the risks associated with ONTRUZANT®. For additional information on ONTRUZANT® indications, as well as Important Safety Information related to its use, including Boxed WARNINGS, please see the ONTRUZANT® Prescribing Information HERE
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, please visit: www.samsungbioepis.com. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.
iHERCEPTIN is a registered trademark of Genentech Inc.
Contacts
Na Yun KIM
+82-31-8061-1604
nayun86.kim@samsung.com
ZHENGZHOU, China--(BUSINESS WIRE)--In central China’s Zhengzhou city, visiting museums has become a new trend of…
Mollie Pearce, star of the UK reality TV show ‘The Traitors’ who was diagnosed with…
QBA 2024 Announces 35 Finalists Competing for Hong Kong's Highest Honour in the Building Industry…
SINGAPORE - Media OutReach Newswire - 17 May 2024 - UXLINK, the Web3 social platform…
DUBLIN--(BUSINESS WIRE)--The "Australia Construction Market Size, Trend Analysis by Sector, Competitive Landscape and Forecast to…
Three-part podcast interview features The mechanism of action of ANKTIVA® activating NK cells, Killer T…