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…
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 subsequently submitted comments on AbbVie’s petition. On December 1, 2015, FDA issued an interim response to AbbVie’s petition indicating that “FDA has been…
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 (the first approved by FDA) and is used to treat disorders such as rheumatoid arthritis and Crohn’s disease. This is Amgen’s first…
On November 20th, the U.S. Department of Health and Human Services (HHS) held a forum entitled “HHS Pharmaceutical Forum: Innovation, Access, Affordability and Better Health.” A list of the speakers and their biographies is available here, and a link to video recordings of the proceedings is available here. The forum…
On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal products for Human Use (CHMP) recommended the granting of a market authorization for Benepali, a biosimilar intended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. This is the second biosimilar antibody drug that…
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 have written about extensively, here, here, and here, the Federal Circuit recently interpreted two key provisions of the BPCIA in Amgen v. Sandoz. Three cases currently pending before District Courts raise related issues and each have the potential to reach the Federal Circuit. In this post, we provide…