Court Won't Block Amgen's Biosimilar Sales Despite Genentech's Appeal

A panel of judges for the United States Court of Appeals for the Federal Circuit has denied Genentech’s motion to block sales of Amgen’s biosimilar trastuzumab pending the outcome of an ongoing appeal.
Kelly Davio
August 09, 2019
A panel of judges for the United States Court of Appeal for the Federal Circuit has denied Genentech’s motion to block sales of Amgen’s biosimilar trastuzumab pending the outcome of an ongoing appeal.

Last month, Amgen launched the first anticancer biosimilars, Kanjinti (trastuzumab) and Mvasi (bevacizumab) in the United States. The pair of launches came after the United States District Court for the District of Delaware denied a motion from rival drug maker Genentech to block the launch of Kanjinti.

The trastuzumab biosimilar references Roche and Genentech’s Herceptin, and Genentech had asked the court to block Amgen from launching the product. According to the court’s decision in the case, Genentech failed to show that it would suffer irreparable harm if its motion were denied.

It went on to say that, given that Genentech was aware since May 2018 that Amgen planned to launch its biosimilar, and given that Genentech received other information from Amgen in the discovery process that alerted it to the Kanjinti launch date, Genentech’s late request—filed in July 2019—for a restraining order was “contrary to the spirit and purpose of the BPCIA,” which gives parties ample time to adjudicate disputes without seeking immediate intervention by the court.

Next, Genentech filed an appeal. Now, in a 1-page order filed this week, the court denied Genentech’s motion for an injunction that would have barred sales of Kanjinti pending the resolution of the appeal.

According to the panel, “we conclude that Genentech has not established that an injunction pending appeal is warranted here,” though the determination is without prejudice to the ultimate disposition of the case. The panel also said, in response to Genentech’s request to expedite the appeal, that Genentech has not demonstrated that Amgen is able to expedite its filings in the case.

With respect to a separate action related to bevacizumab, which revolved around 2 patents owned by Genentech related to manufacturing processes for bevacizumab, the United States District Court of the District of Delaware also recently denied an emergency motion for a temporary restraining order and a prohibition on commercial marketing of Amgen’s Mvasi, which references Genentech’s Avastin.

Genentech had argued that because the FDA approved supplements to Amgen’s Biologics License Application (BLA) for the biosimilar, Amgen should provide new notices of marketing related to those supplements.

The court disagreed, saying that the Mvasi product that was subject to the FDA’s original approval is the same as the product for which supplements to the BLA were also approved. The court found that Genentech could not succeed on the merits, and “that finding alone necessitates denial of Genentech’s motion.”

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