Blog Big Molecule Watch July 08, 2020

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 dismiss all asserted claims and counterclaims with prejudice.

The settlements come on the heels of two recent appellate decisions in these litigations from the U.S. Court of Appeals for the Federal Circuit. The appeals stemmed from the district court’s July 2019 denials of Genentech’s motions for preliminary injunctions and temporary restraining orders to enjoin Amgen’s U.S. launch of its biosimilars, KANJINTI (trastuzumab-anns) and MVASI (bevacizumab-awwb). Amgen launched both biosimilars immediately following the decisions. In March 2020, the Federal Circuit affirmed the lower court ruling in the trastuzumab case, and yesterday affirmed the bevacizumab ruling. Today, the parties also advised the Federal Circuit of their settlement in the bevacizumab case, indicating that, “[a]ccordingly, Genentech will not petition for any further review of this Court’s decision.”

Further details of the settlements were not disclosed in the parties’ court submissions.

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