Search Results for: "herceptin" and "roche"

FDA Approves New Trastuzumab Product

On February 28, 2019, the FDA approved Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk).  According to a press release from Roche, Genentech’s parent company:  “This new treatment includes the same monoclonal antibody as intravenous Herceptin® (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under…

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Prestige Biopharma Partners with Cipla Ltd. for Trastuzumab Biosimilar

On December 14, 2018, Prestige Biopharma (“Prestige”) announced a partnership with Cipla Ltd. (“Cipla”) for Prestige’s HD201, a proposed trastuzumab biosimilar of Roche’s Herceptin®.  Prestige’s HD201 is in Phase-3 clinical development for the treatment of patients with HER2-overexpressing breast cancer. According to the press release, under the agreement, Cipla will…

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Q1 2018 Earnings Roundup: Biosimilars Update

Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls.  Below are some highlights: On April 17, Johnson & Johnson (J&J) reported a 22.5% year-over-year (YOY) decline in U.S. sales of Remicade® (infliximab), which it attributed “to increased discounts/rebates,…

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FDA Approves Ogivri, Mylan’s Biosimilar Version of Herceptin

Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab).  Ogivri is indicated for adjuvant treatment of breast cancer and treatment of metastatic breast cancer or stomach cancer in patients whose tumors overexpress the HER2 gene.  Ogivri is the first biosimilar version…

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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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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…

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FDA Advisory Committee to Hold Public Meetings on Amgen’s Proposed Bevacizumab Biosimilar and Mylan’s Proposed Trastuzumab Biosimilar

  The FDA announced today that the Oncologic Drugs Advisory Committee will hold a public meeting on July 13, 2017 in Silver Springs, Maryland to discuss two biosimilar applications.  During the morning session, the committee will discuss Amgen’s application for a proposed biosimilar of Genentech/Roche’s AVASTIN (bevacizumab). During the afternoon session,…

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Mylan Obtains Global License to Trastuzumab in IPR Settlement

Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab).  As part of the settlement, Mylan agreed to withdraw its IPR challenges to U.S. Pat. Nos.  6,407,213 and 6,331,415….

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