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J&J loses Remicade patent fight, pledges to continue fight against biosimilars

Published on 18/08/16 at 09:41am

Johnson and Johnson has announced that it has lost in a patent dispute between biosimilar makers Celltrion and Hospira, relating to its autoimmune disease drug Remicade (infliximab).

A District of Massachusetts Federal Court has issued a ruling in favour of Celltrion and Hospira, declaring that US Patent no 6,284,471 for Remicade (‘471 patent) is invalid. J&J’s pharmaceutical arm, Janssen, has declared disappointment with the court’s ruling, indicating that it plans to appeal to the Court of Appeals for the Federal Circuit. They will also continue appealing the patent decision before the US Patent & Trademark Office.

Their statement says: “Janssen will continue to defend its intellectual property rights relating to its innovative medicines. A commercial launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch.”

It may be no surprise that the company plans to continue the fight against biosimilar versions of their $4.5 billion a year drug. However, with Remicade biosimilars approved across Europe and the FDA beginning to warm to biologics copies, J&J may be fighting a losing battle.

Crucially, dispensers of drugs could play a key role in the biosimilar battle. US pharmacy chain CVS Health recently announced that it was embracing “the future with biosimilars and follow-on biologics”. It already covers Sandoz biosimilar Zarxio, replacing Amgen’s Neupogen. Celltrion has indicated that the expected price of their biosimilar version of Remicade will come in at 20-30% less than the price of the originator.

J&J meanwhile has reaffirmed its sales guidance for operational sales growth for the full-year 2016 of 3-4%, “notwithstanding the possibility of a biosimilar launch on or after October 3 2016”.

Sean Murray

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