Big Day for Celltrion’s Infliximab Product

Biosimilar News

Yesterday, the FDA’s Advisory Committee overwhelmingly supported approval of Celltrion’s infliximab product, which is a biosimilar for Janssen’s Remicade product.

At the District Court status conference in Janssen v. Celltrion, which followed the Advisory Committee vote, Celltrion’s counsel said that Celltrion is expecting FDA approval in about four to eight weeks. However, Celltrion’s counsel stated that Celltrion would not launch until after June 29, 2016, which is the expiration date of the patent covering the Crohn’s disease indication of infliximab.

Janssen has brought a motion to stay the litigation pending its appeal of the PTAB’s recent decision invalidating the patent covering the infliximab product. A hearing on this motion will be scheduled for March 14 or 15.

Janssen’s motion for a preliminary injunction to prevent Celltrion from launching prior to the expiration of the 180 day notice period remains pending. The parties have agreed that this issue will not be decided until after the Federal Circuit decides in Amgen v. Apotex whether the 180 day notice period is mandatory.

Also pending is Janssen’s motion to amend the protective order to allow it to assert claims regarding an additional patent, as we previously reported. A hearing on this issue will take place on March 14 or 15 along with the motion for a stay.

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