Search Results for: "herceptin"

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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Genentech Files Complaint Against Pfizer Regarding Herceptin

Genentech filed a complaint last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab).  According to the complaint, the FDA accepted Pfizer’s aBLA for review on August 21, 2017. Genentech’s complaint acknowledges that the parties had started, but not completed, the information exchanges of the…

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IPR Updates

The PTAB remains a busy venue for biologics patents.  Here are some IPR updates from the weeks since our last IPR update: HERCEPTIN On October 4, the Board instituted IPR on four petitions that Celltrion had filed on Genentech patents related to Herceptin® (trastuzumab): IPR2017-01121 (challenging U.S. Patent 7,846,441); IPR2017-01122 (challenging U.S. Patent No….

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Recent IPR Updates

The PTAB has been a busy place for biologics patents in the past few weeks.  Here are some of the highlights: On August 29, Pfizer filed two petitions for IPR of Genentech’s U.S. patents related to formulations of Herceptin® (trastuzumab):  IPR2017-02019 on U.S. Patent 6,339,142 and IPR2017-02020 on U.S. Patent 9,249,218….

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Amgen/Allergan and Pfizer Present Positive Phase 3 Data For Two Investigational Trastuzumab Biosimilars

At the European Society for Medical Oncology (“ESMO”)  2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of Herceptin (trastuzumab). First, Amgen presented Phase 3 study data on ABP980, which it is co-developing with Allergan plc, comparing the safety…

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Samsung Bioepis Files for Joinder With Hospira Petitions Against Genentech Patents

Samsung Bioepis has filed three petitions for IPR challenging Genentech patents related to the use of Herceptin® (trastuzumab): IPR2017-01958, challenging U.S. Patent 6,627,196; IPR2017-01959 challenging U.S. Patent 7,371,379; and IPR2017-01960 challenging U.S. Patent 7,892,549.  Samsung Bioepis concurrently filed motions for joinder with Hospira’s petitions challenging the same patents (IPR2017-00804, IPR2017-00805, and…

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Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for Proposed Biosimilars of Herceptin®

Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer. First, Celltrion and Teva announced that the FDA has accepted for review a BLA…

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FDA Committee Recommends Approval of Bevacizumab and Trastuzumab Biosimilars

The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously supported biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab). Amgen and Allergan’s Avastin biosimilar candidate, ABP 215, was reviewed for six of eight of Avastin’s indications. Mylan and Biocon’s Herceptin biosimilar candidate, MYL-1401O, was reviewed for all of Herceptin’s indications….

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