As part of our continuing coverage, we are following the parties’ briefing in the appeal of the preliminary injuction, which prohibits Apotex’s launch of its pegfilgrastim biosimilars,…
As part of our continuing coverage, we are following the parties’ briefing in the appeal of the preliminary injuction, which prohibits Apotex’s launch of its pegfilgrastim biosimilars,…
…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…
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…
After winning a preliminary injunction in Amgen v. Apotex, Amgen now hopes to capitalize on that win in another pending BPCIA case, Amgen v. Hospira, which is being litigated in…
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…
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…
The order can be found here. Analysis to…
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…
As we’ve previously reported, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants, and several other entities…
On December 4th, Amgen submitted a Marketing Authorization Application to the EMA for a biosimilar candidate (ABP 501) to Humira (adalimumab). Adalimumab is an anti-TNF-α human monoclonal antibody…