As we’ve covered previously, Apotex has moved to expedite the briefing schedule for its appeal of the district court order in Amgen v. Apotex, in which the district court granted Amgen a preliminary injunction prohibiting Apotex from launching its biosimilar pegfilgrastim product until at least 180 days after FDA licensure of the product. Today,…
As we covered last week (here), Apotex is appealing the district court’s grant of a preliminary injunction to Amgen in Amgen v. Apotex. Apotex has now moved to expedite the briefing schedule on its appeal in the Federal Circuit. In its motion, Apotex explains: “Under the district court’s order, Apotex suffers immediate harm because the launch…
As we covered yesterday, the district court issued an order in Amgen v. Apotex granting Amgen a preliminary injunction that would prohibit Apotex from launching its biosimilar pegfilgrastim product until 180 days after it receives FDA approval and gives notice of commercial marketing. Today, Apotex filed a notice of appeal…
We’ve been covering Amgen’s motion for a preliminary injunction in Amgen v. Apotex, where Amgen sought to prevent Apotex from marketing its biosimilar pegfilgrastim product until 180 days after Apotex notifies Amgen that its biosimilar application has received FDA approval and that Apotex intends to begin commercial marketing (see our post on the…
The order can be found here. Analysis to follow shortly.
Last Thursday, December 3, the U.S. district court for the Southern District of Florida heard oral arguments on Amgen’s motion for a preliminary injunction in Amgen v. Apotex. As we’ve discussed in previous posts (here, here, and here), Amgen is seeking a preliminary injunction to prevent Apotex from launching its…
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…
As we’ve covered previously (here and here), Amgen has moved for a preliminary injunction to prevent Apotex from launching its biosimilar version of Amgen’s Neulasta until at least 180 days after FDA licensure of Apotex’s product. In its reply to Apotex’s opposition to its motion for a preliminary injunction, Amgen reiterates its…
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…
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…