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Samsung Bioepis' cancer-treating biosimilar Ontruzant is available in U.S.

By Lim Chang-won Posted : April 16, 2020, 17:31 Updated : April 16, 2020, 17:31

[Courtesy of Samsung Bioepis]

SEOUL -- Ontruzant, a cancer-treating biosimilar referencing Herceptin, is available in the United States, according to Samsung Bioepis, a U.S. and South Korean biopharmaceutical joint venture company.

Trastuzumab, sold under the brand name Herceptin, is a monoclonal antibody used to treat breast cancer developed by Swiss pharmaceutical giant Roche. Samsung Bioepis said Ontruzant is available in both 150 mg single-dose vials and 420 mg multi-dose vials.

Samsung Bioepis said that Ontruzant would be introduced at a list price of about $1,325 for the 150 mg single-dose vial and $3,709 for the 420 mg multiple-dose vial, representing a 15 percent discount to the current list price of Herceptin,

"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," Samsung Bioepis CEO Christopher Ko said in a statement.

"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," Ko said.

Samsung Bioepis said it 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.

Samsung Bioepsis, a joint venture between Biogen, a U.S.-based pharmaceutical company, and Samsung BioLogics, a bio company affiliated with South Korea's largest Samsung Group, has been known for Imraldi, an adalimumab biosimilar referencing Humira. In 2019, the company won U.S. approval to sell its biosimilar referencing Enbrel (etanercept), one of the best-selling pharmaceutical products, that treats chronic diseases, including moderate to severe rheumatoid arthritis.

In January this year, Samsung Bioepis won Chinese approval to go ahead with Phase 3 clinical trial for SB12, a biosimilar candidate referencing Soliris (Eculizumab), a high-priced drug developed by Alexion Pharmaceuticals of the United States.

SB12 was developed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare disease in which the destruction of red blood cells leads to red discoloration of the urine. Soliris has been used to treat the rare disorders atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria.

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