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…
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….
IPR2016-00172 (Coherus BioSciences Inc.) (U.S. Patent No. 8,889,135) Petitioner: Coherus BioSciences Inc. Patent: U.S. Patent No. 8,889,135 Patent Title: Methods of…
Last Friday, Oct. 30, Janssen filed a motion for leave to file a brief as amicus curiae in support of Amgen in Amgen v. Apotex. As we’ve covered in previous…
On October 29, 2015, Amgen filed its answer to Apotex’s counterclaims in the Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As background, Amgen’s complaint alleged that Apotex provided…
Last year, Hospira, Inc. (owned by Pfizer, Inc.) submitted an abbreviated Biologics License Application (aBLA) for its proposed biosimilar to Amgen’s Epogen (epoetin alfa). The biosimilar…
The Federal Circuit today issued its formal mandate in Amgen v. Sandoz, as promised in its October 16th order denying the parties’ petitions for rehearing in the case. With the…
As we reported in an earlier post, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants. Since then, several entities…
IPR2015-01514 (Amgen Inc.) (U.S. Patent No. 8,916,157) Petitioner: Amgen Inc. Patent: U.S. Patent No. 8,916,157 Patent Title: Formulation of human antibodies for treating TNF-α associated…