FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Court: Hospira Wasn’t Protected by Safe Harbor in $70 Million Biosimilars Case

Oct. 8, 2018

A federal court in Delaware refused to undo a 2017 decision awarding $70 million to Amgen in its patent infringement battle with Hospira.

Last September, a federal jury found that Hospira’s biosimilar for Epogen (epoetin alfa), a treatment for anemia caused by chronic kidney disease, violated a key Amgen patent. In the initial trial, Hospira argued it needed its batches of the drug as part of the FDA’s approval process for biosimilars.

Hospira moved for a judgment that producing biosimilar batches is protected under safe harbor—and that it didn’t owe damages greater than $1.5 million per batch of drugs later sold.

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