Janssen Sues Biosimilar Maker Celltrion Over Remicade Patent

June 8, 2017

Janssen Biotech is suing Celltrion and Hospira in the latest of a series of lawsuits related to its blockbuster Remicade (infliximab) therapy.

The suit, filed in Massachusetts federal court, says the cell culture media used by Celltrion to produce its biosimilar Inflectra (infliximab-dyyb) infringes one of Janssen’s patents — covering 61 ingredients at various concentrations. It expires in February 2027.

Inflectra was approved by the FDA in April 2016 and marketed later that year. It has been available in South Korea, however, since 2012, and in Europe since 2015.

Remicade, which carries FDA approvals in 16 indications, brought in nearly $7 billion last year, making up 9.7 percent of the total sales of Janssen’s parent company, Johnson & Johnson. It was first approved in 1998 for Crohn’s disease, and would later be approved for rheumatoid and psoriatic arthritis, ulcerative colitis and plaque psoriasis.

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