Samsung Bioepis’ Trastuzumab Biosimilar Is Third Cleared By FDA – But The Market Hasn’t Formed Yet
Sued by Herceptin sponsor Genentech for patent infringement, Samsung Bioepis has legal hurdles to navigate before it can roll out its trastuzumab biosimilar in the US, which has just become the third biosimilar of the cancer treatment greenlit by the FDA.
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Ahead of launching potentially its Lucentis biosimilar in the EU early next year, Samsung Bioepis has reported two lots of positive analysis involving its Byooviz biosimilar, at the same time as it disclosed the findings of a five-year follow-up study for its trastuzumab biosimilar, Ontruzant.
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.
Mylan and Biocon have launched their Ogivri trastuzumab biosimilar in the US, marking the second biosimilar rival to Herceptin and leading a new wave of trastuzumab biosimilars expected to arrive in the US early next year.