As previously reported, Genentech and Tanvex reached an agreement in January 2022 to settle BPCIA litigation relating to Tanvex’s biosimilar of HERCEPTIN (trastuzumab).  On February 9, the court entered an order dismissing all claims in the case.  Tanvez’s trastuzumab biosimilar has not yet been approved by FDA.

Genentech previously settled cases filed against Pfizer, Celltrion/Teva, Amgen, and Samsung Bioepis/Merck involving their respective trastuzumab biosimilars.  In 2017, Genentech also reached a settlement with Mylan in relation to Genentech’s patents for HERCEPTIN (trastuzumab), in which Mylan agreed to withdraw two IPR challenges.  Each company has commercially launched their trastuzumab biosimilars in the United States–Amgen launched KANJINTI (trastuzumab-anns) in July 2019, Mylan launched OGIVIRI (trastuzumab-dkst) in December 2019, Pfizer launched TRAZIMERA (trastuzumab-qyyp) in February 2020, Teva launched HERZUMA (trastuzumab-pkrb) in March 2020, and Samsung Bioepis launched ONTRUZANT (trastuzumab-dttb) in April 2020.

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