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Samsung Bioepis’ Trastuzumab Biosimilar Is Third Cleared By FDA – But The Market Hasn’t Formed Yet

 
• By Dean Rudge

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.

Korea
Incheon-based Samsung Bioepis faces a wait to roll out its second biosimilar • Source: Shutterstock

Samsung Bioepis has received US Food and Drug Administration (FDA) approval for its Ontruzant (trastuzumab-dttb) biosimilar for intravenous injection, the third biosimilar of Genentech’s Herceptin (trastuzumab) blockbuster approved in the US and the Korea-based joint venture’s second FDA-approved product.

Partner Merck Sharp & Dohme will handle commercialization of the breast and gastric cancer treatment upon market entry

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