Court of Appeals for the Federal Circuit Declines to Halt Sales of Biosimilar Bevacizumab

In a one-page order filed last week, a panel of judges for the US Court of Appeals for the Federal Circuit denied Genentech’s motion for an injunction that would have blocked Amgen from selling its biosimilar bevacizumab, Mvasi, pending the outcome of an appeal.

The latest legal development stems from a dispute over the notice of commercial marketing for the biosimilar. In September 2017, the FDA approved the biosimilar, and in October of the same year, Amgen sent Genentech, maker of the reference bevacizumab, Avastin, its notice of commercial marketing. The letter indicated that Amgen would not launch the drug earlier than 180 days from the letter’s date.

After giving Genentech its notice, Amgen filed a number of supplements to its Biologics License Application (BLA) with the FDA, including changes to the labeling for the biosimilar.

According to Genentech, because Amgen had filed these supplements, the Mvasi product authorized by the FDA after the supplements were approved was different from the product approved in 2017. Genentech sought an order prohibiting Amgen from marketing the biosimilar until 180 days after filing a new notice of commercial marketing.

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.”

Genentech then sought an injunction on sales of Mvasi pending an appeal of that decision.

According to the court’s order issued on Friday, determining whether to grant an injunction takes into account 4 factors: whether the party moving for an injunction has a strong likelihood of succeeding on the merits, whether that party will be irreparably injured without an injunction being granted, whether an injunction would injure other parties, and where the public interest lies.

“Without prejudicing the ultimate disposition of this case, we conclude that Genentech has not established that an injunction pending appeal is warranted here under these factors,” the court’s order read.

Earlier this month, the court also denied Genentech’s motion for an injunction that would have barred sales of another Amgen biosimilar, Kanjinti (a trastuzumab biosimilar referencing Genentech’s Herceptin) pending the resolution of an appeal in a separate case.

Mvasi and Kanjinti were launched simultaneously last month, and have enjoyed early support; provider group OneOncology indicated that it has begun treating patients with the agents, and UnitedHealthcare has announced that it will make both of the biosimilars preferred oncology agents on its formulary as of October 2019.