Search Results for: "amgen v apotex"

Amgen Submits Application for Biosimilar Version of Humira (adalimumab)

Amgen today announced the submission of its first biosimilar application to FDA. The application seeks approval for a biosimilar version of Humira®(adalimumab). As we’ve covered extensively, Amgen is the biologic reference product sponsor and plaintiff in a number of BPCIA cases: Amgen v. Sandoz, Amgen v. Hospira, and Amgen v. Apotex.  This is the first time Amgen has formally appeared on…

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Apotex opposes Amgen’s motion for PI

On Friday, November 16, 2015, Apotex filed its brief in opposition to Amgen’s motion for a preliminary injunction in Amgen v. Apotex.  As we’ve discussed previously here, Amgen has moved to enjoin Apotex from marketing its yet-to-be-approved Neulasta biosimilar until at least 180 days after FDA approval.  Amgen has taken…

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Supplemental Scheduling Order Issued In Amgen v. Apotex

Yesterday Judge Cohn issued a supplemental scheduling order in Amgen v. Apotex.  The hearing for Amgen’s Motion for Preliminary Injunction has been rescheduled for December 3, 2015.  Claim construction briefing will occur in December and January, and the claim construction hearing will be held on February 5, 2016.  Expert reports…

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Update in Amgen v. Apotex: Amgen Files Preliminary Injunction Blocking Apotex from Marketing Neulasta Biosimilar

As discussed in earlier coverage, Amgen has now made good on its intention to seek a preliminary injunction against Apotex.  Amgen looks to block Apotex from marketing its Neulasta biosimilar before the expiration of the 180-day pre-marketing notice following FDA approval. Apotex has previously argued that the Federal Circuit’s panel decision…

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Update in Amgen v. Apotex: Apotex’s Answer and Counterclaims

On October 5, 2015, Apotex filed its answer and counterclaims in the ongoing Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As we previously reported, Amgen’s complaint alleged that Apotex provided Amgen with an “ineffective” Notice of Commercial Marketing pursuant to 42 U.S.C. § 262(l)(8)(A), because “a subsection (k) applicant may only give…

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Update in Amgen v. Apotex: Scheduling Report

As we reported in an earlier post, Amgen v. Apotex is the first biosimilar litigation in which the parties have actually danced the entire “patent dance” through the “first wave.” The case, which concerns Apotex’s application to market a biosimilar version of Neulasta, has already been scheduled for trial beginning July…

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