Search Results for: "genentech v pfizer"

FDA approves a fourth biosimilar of HERCEPTIN

Yesterday, the U.S. FDA approved Pfizer’s Trazimera™ (trastuzumab-qyyp), a biosimilar of Genentech’s Herceptin®, for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  These indications are the same as those for which the reference product is approved. Trazimera™ is the fourth trastuzumab biosimilar, and the…

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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 or some of our prior BPCIA litigation coverage. # Litigation Accused Biosimilar [status] Reference Product Complaint Filed Status/Outcome District Court Appeal 1 Amgen v….

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BPCIA Litigation Roundup (Fall 2017)

Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017, Summer 2017).

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