Samsung Bioepis Receives FDA Approval for Large-Dose Breast Cancer Treatment

[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis announced on the 20th that it received approval from the U.S. Food and Drug Administration (FDA) on the 19th (local time) to market the large-dose product (420 mg) of the breast cancer biosimilar 'Ontruzant.'

Ontruzant is a biosimilar product of 'Herceptin,' sold by the Swiss multinational pharmaceutical company Roche. Samsung Bioepis obtained marketing approval in the United States in January 2019.

Samsung Bioepis initially received approval for the 150 mg dosage product and then pursued approval for the large-dose product to meet various prescription demands.

Currently, Samsung Bioepis is preparing to launch Ontruzant in the U.S. together with its marketing partner Merck. Earlier, Samsung Bioepis resolved uncertainties regarding the product launch by settling a patent dispute with Genentech, the original developer of Herceptin, last year.

A Samsung Bioepis official stated, "By introducing the large-dose product, we aim to provide patients with more effective treatment opportunities."

This content was produced with the assistance of AI translation services.