Samsung Bioepis Gets Higher Strength Trastuzumab Nod
Both 150mg And 420mg Vials Of Ontruzant Biosimilar Now Approved
Although Merck has not yet debuted the Ontruzant version of trastuzumab developed by Samsung Bioepis in the US, the firm can now look to introduce two strengths of the Herceptin biosimilar, ahead of plans to spin off its biosimilar assets into a new company next year.
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Merck & Co has launched Ontruzant, the trastuzumab biosimilar developed and manufactured by Samsung Bioepis, in the US following a staggered approval process and earlier intellectual-property hurdles. The list price discount offered by the firm puts it in the middle of the pack among the four other biosimilar players currently on the market.
Teva and Celltrion have launched their Herzuma trastuzumab biosimilar in the US at a 10% discount to the Herceptin brand. The discount matches that offered for their Truxima rituximab biosimilar and compares to steeper discounts offered by competing biosimilars.
Merck has announced plans to spin off its Biosimilars, Women’s Health and Legacy Brands units into a separate company.