FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

Janssen Files Lawsuit Against GE Subsidiary Over Remicade Biosimilar

June 23, 2016

The patent dispute over Janssen’s Remicade continues to balloon, with the drugmaker suing GE Healthcare subsidiary HyClone Laboratories over the use of cell cultures to grow a biosimilar of the drug.

Janssen alleges in the lawsuit that HyClone infringed a patent covering the particular compositions of cell culture media used to make the Remicade knock-off, which Celltrion sells as Remsima and Hospira sells as Inflectra. The suit was filed in U.S. District Court for the District of Utah. Inflectra was approved for sale in the U.S. in April.

The patent in question specifically covers cell culture media for use in growing antibody-producing cells. According to the complaint, HyClone’s cell culture media include all of the ingredients required by the patent in precisely the same chemical forms.

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