Tony Hagen is senior managing editor for The Center for Biosimilars®.
In upholding a lower court ruling, a federal circuit court has decided that Amgen gave enough notice prior to launching its bevacizumab biosimilar. The court decision has frustrated an attempt by Genentech to block sales of the product.
A federal circuit court has overruled an attempt by Genentech to stop Amgen from selling a bevacizumab biosimilar (Mvasi) in the United States. The ruling was an affirmation of a district court’s earlier opinion affirming Amgen’s right to market the drug.
Genentech, which markets the reference drug Avastin, sought an injunction contending that Amgen had failed to provide adequate notice in advance of commercialization. However, the US Court of Appeals for the Federal Circuit sided with Amgen, saying the notice Amgen had provided was in accord with provisions of the Biologics Price Competition and Innovation Act (BPCIA).
Bevacizumab is a treatment used for colorectal, lung, glioblastoma, kidney, cervical, and ovarian cancers. Amgen began selling Mvasi in July 2019 following marketing authorization from the FDA in September 2017.
Notice of Commercialization
In July 2019, Genentech filed a motion to block the sale of the product. Under the BPCIA, biosimilar developers are required to provide at least 180 days’ notice of commercialization, which Amgen did provide in October 2017. Genentech contended that notice was inadequate because of subsequent changes made to Amgen’s Biologics License Application for marketing approval.
Those changes had to do with adding a manufacturing facility and drug labeling. Genentech contended the supplements to the application represented new and distinct applications.
Genentech contended the changes technically made Mvasi a different biological product under the BPCIA than the one that was the subject of the original notice of commercialization. Amgen should have filed a second notice of commercialization and waited another 180 days before commencing its sales effort, Genentech said.
In its disagreement with that argument, the district court had stated, “the fact that Mvasi was the subject of the original application approved by the FDA in September 2017 does not make it a different biological product than the Mvasi that was the subject of the supplements to the application approved by the FDA in December 2018 and June 2019.”
In its affirmation of that opinion, the higher court stated, “Genentech…had notice of Amgen’s intent to commercially market Mvasi as required…as early as October 6, 2017.”
The circuit court added clarity to the issue of whether supplements during the application process materially affect licensees’ obligations to update notices of commercialization, noting that a “biosimilar applicant that has already provided Section 262(l)(8)(A) notice regarding its biological product need not provide another notice for each supplemental application concerning the same biological product.”
Mvasi had $108 million in sales in the United States during the first quarter of this year, and its share of the US market for bevacizumab is 33%, according to Amgen. Global sales of Avastin topped $7 billion last year, fueled by growth in China.