Search Results for: "janssen v celltrion"

Big Day for Celltrion’s Infliximab Product

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…

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FDA Scientists Express View that Celltrion’s Infliximab Biosimilar is "Highly Similar" to Remicade, Meet Today to Discuss Application

Following FDA support announced last Friday for Celltrion’s proposed Remicade® biosimilar (“CT-P13”), the FDA is holding an Advisory Committee meeting today to discuss Celltrion’s application. On Friday, the FDA said that based on its review of the data, Celltrion’s CT-P13 has been demonstrated to be highly similar to Remicade, notwithstanding…

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Busy Month Ahead for BPCIA Interpretation Questions

February will be a busy month for pending BPCIA cases, with activity on the horizon in Amgen v. Apotex, Amgen v. Hospira, and Janssen v. Celltrion: Amgen v. Apotex (Fed. Cir.) As we covered previously, Apotex appealed the district court’s order granting Amgen a preliminary injunction in Amgen v. Apotex. Apotex requested an expedited briefing…

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UPDATE in Janssen v. Celltrion: Stipulation of Voluntary Dismissal Narrows Issues to be Litigated

The parties in Janssen v. Celltrion have filed a stipulation of voluntary dismissal narrowing the issues in the litigation.  While it does not dispose of all patent infringement claims in suit, the stipulation narrows the case as follows: Defendants will not launch any biosimilar infliximab product in the United States until after September 15, 2015, the date…

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Janssen v. Celltrion: Motion to Modify Protective Order

In addition to the pending cross-motions for partial summary judgment on which we’ve previously reported, the parties in the Janssen v. Celltrion BPCIA litigation recently completed briefing on the issue of whether the district court should permit Janssen to use confidential information obtained through discovery as a basis for a…

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Janssen v. Celltrion Supplemental Briefing in Light of Amgen v. Sandoz: Opposition Brief from Celltrion and Hospira

As we reported in a previous post, the parties in Janssen v. Celltrion–a BPCIA-related case pending in the District of Massachusetts—are currently litigating whether Celltrion’s pre-FDA-licensure notice of commercial marketing was legally effective under the BPCIA. The parties have filed cross-motions for partial summary judgment on this issue, and these motions were pending when the Federal Circuit issued…

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