Search Results for: "genentech v celltrion trastuzumab"

FDA Approves Celltrion's Trastuzumab Biosimilar

Today, the FDA approved Celltrion’s Herzuma (trastuzumab-pkrb), a biosimilar that references Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer, in accordance with the FDA-approved label.  Celltrion’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This marks the seventh biosimilar the FDA has approved…

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BPCIA Litigation Roundup (Q2 2018)

Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017, Q1 2018). Please also refer to our BPCIA Patent Litigation and Federal…

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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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New BPCIA Litigations Regarding Celltrion's Trastuzumab and Rituximab Biosimilars

On January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District Court for the Northern District of California.  Case No. 3:18-cv-00274 relates to Celltrion’s Herzuma®, its trastuzumab biosimilar. According to the complaint, Celltrion and Teva seek a declaratory judgment of non-infringement, invalidity, and/or unenforceability of 38…

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