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…
The Federal Circuit recently denied en banc rehearing of Ariosa Diagnostics, Inc. v. Sequenon, Inc.. The original panel decision is at 788 F.3d 1371, (Fed. Cir. Jun. 12, 2015). In the original panel decision, Judges Linn, Wallach, and Reyna decided that the claims at issue were drawn to not- patentable…
On December 7 Samsung Bioepis and Merck announced that Samsung Bioepis had received approval for its RENFLEXIS product by the Ministry of Food and Drug Safety in Korea. RENFLEXIS, a biosimilar version of Janssen Biotech’s Remicade (infliximab), was approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative…
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 the District of Delaware. Amgen filed a notice of supplemental authority in the Hospira case citing the Florida District Court’s order in Apotex in an attempt to provide further support for…
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…