Search Results for: "genentech v samsung bioepis trastuzumab"

FDA Approves Samsung Bioepis’s Trastuzumab Biosimilar

Today, the FDA approved Samsung Bioepis’s Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  Samsung Bioepis’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This is the third biosimilar…

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New BPCIA Complaint: Genentech Sues Samsung Bioepis Regarding Proposed Trastuzumab Biosimilar (UPDATED)

Yesterday, September 4, 2018, Genentech filed a complaint against Samsung Bioepis in the District of Delaware alleging infringement under the BPCIA of 21 patents based on Bioepis’s filing of an aBLA for SB3, a biosimilar candidate referencing Herceptin® (trastuzumab).  This is the fourth litigation regarding a biosimilar of Herceptin®, following…

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BPCIA Litigations

The table below chronologically lists the U.S. patent litigations filed under the BPCIA regarding aBLAs for biosimilar products.  For additional details, please consult the links below and our quarterly BPCIA litigation roundup. # Litigation Accused Biosimilar [status] Reference Product [suit#] Complaint Filed Status/Outcome District Court Appeal 1 Amgen v. Sandoz,…

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