Samsung Bioepis Co., Ltd. announced today that ONTRUZANT (trastuzumab-dttb), a biosimilar of the reference biologic medicine HERCEPTI(trastuzumab) for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma, is now available in the United States. Patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ONTRUZANT is available in both 150 mg single-dose vials and 420 mg multi-dose vials. Please see Boxed Warnings and Important Safety Information for ONTRUZANT below.

The launch follows the approval from the US FDA in January 2019 for the 150 mg vial and in March 2020 for the 420 mg vial, based on Samsung Bioepis’ comprehensive data package, including analytical, nonclinical and clinical pharmacokinetic, safety and effectiveness data demonstrating that ONTRUZANT is highly similar to its reference product HERCEPTIN®, and there are no clinically meaningful differences in terms of the safety, purity and potency of the product.i,ii,iii,iv,v,vi

“The launch of ONTRUZANT® to deliver our first oncology biosimilar in the US marks an important milestone for Samsung Bioepis, and more importantly, for the patients who are in need of this proven treatment,” said Christopher Ko, President and Chief Executive Officer, Samsung Bioepis. He continued, “While we understand that this is an unprecedented time for our hospitals and healthcare workers, we at Samsung Bioepis remain steadfastly committed to the patients we serve through our efforts to ensure the continued supply of our medicines through collaboration with our manufacturing and commercial partners.”

ONTRUZANT will be marketed and distributed in the US by Merck (known as MSD outside the US and Canada), which announced on February 5, 2020, that it intends to spin-off certain products, amongst them ONTRUZANT® and its biosimilars businesses, 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.

Under terms of agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration while Merck is responsible for commercialization activities for products approved in its partnered territories, including the US.