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…
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…
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…
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…
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…
Yesterday, Sandoz announced that the FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim). This…
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…
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…
In the wake of Amgen’s decision to drop Count II from its Complaint, which sought declaratory judgment that Hospira’s failure to provide manufacturing information violates 42 U.S.C. §…
On November 9, Amgen gave the latest signal of its intention to market a biosimilar to AbbVie’s Humira (adalimumab) by presenting detailed findings from a head-to-head phase III clinical study….