Search Results for: "herceptin"

BREAKING NEWS: Genentech and Amgen Settle HERCEPTIN and AVASTIN Biosimilar Disputes

Today, Genentech and Amgen jointly filed stipulations in the U.S. District Court for the District of Delaware dismissing their BPCIA litigations concerning Amgen’s biosimilars of Genentech’s HERCEPTIN (trastuzumab) and AVASTIN (bevacizumab) oncology products. According to each court submission, the parties entered into a settlement agreement and mutually agreed to voluntarily…

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Biosimilar Market Updates

Shanghai Henlius biosimilar antibody developments On March 9, 2020, Shanghai Henlius Biotech, Inc. announced that its investigational new drug application has been accepted by China’s National Medical Products Administration (NMPA) for HLX14, a biosimililar to Amgen’s PROLIA (denosumab).  According to the press release, HLX14 is indicated for the treatment of…

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Russian Pharma Company Biocad Obtains European Certification for Biosimilars to Treat Cancer

On March 30, 2020, Russian pharmaceutical company, Biocad, announced that it and its partner, ICM d.o.o., recently obtained European registration certification in Bosnia and Herzegovina for two cancer treatment biosimilars:  Acellbia (rituximab), a biosimilar of Roche’s MabThera®, and Herticad (trastuzumab), a biosimilar of Roche’s Herceptin®.  According to Biocad, the registration…

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BREAKING NEWS: Federal Circuit Rejects Genentech’s Bid to Block Sales of Amgen’s Trastuzumab Biosimilar

Following the oral argument three days ago, the U.S. Court of Appeals for the Federal Circuit today affirmed the lower court’s denial of Genentech’s motion for a preliminary injunction to enjoin sales of Amgen’s KANJINTI (trastuzumab-anns) biosimilar product. As we previously reported, Amgen launched KANJINTI in the United States in…

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Trastuzumab Appeals Update

Last week, several briefs were filed in Federal Circuit appeals relating to trastuzumab biosimilars: Trastuzumab IPR Appeals On September 3, 2019, the USPTO submitted responsive appellate briefs in Federal Circuit appeals from IPR final written decisions regarding two patents related to methods of treating HER2+ cancer with trastuzumab (Cases Nos….

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DEAL WATCH: Recent Biosimilar Collaboration Announcements

In recent weeks, several drug makers announced collaborations for the development, manufacture, and/or commercialization of a variety of biosimilars or follow-on biologics.  Below are some highlights: On September 3, 2019, Polpharma Biologics and Sandoz announced that they have entered into a global commercialization agreement in connection with Polpharma’s proposed biosimilar…

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United Healthcare and OneOncology Update Preferred Products to Include Biosimilars

United Healthcare and OneOncology have added Amgen’s MVASI (bevacizumab-awwb) and KANJINTI (trastuzumab-anns), biosimilars to AVASTIN and HERCEPTIN respectively, as preferred products, according to literature released by those providers. United Healthcare released a bulletin indicating that, as of October 1, 2019, United Healthcare will update its preferred product language to reflect…

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