About 12 months ago, AbbVie filed a Citizen Petition asking the FDA to take certain steps to tighten and clarify its procedures for making interchangeability determinations. Earlier this year, both…
About 12 months ago, AbbVie filed a Citizen Petition asking the FDA to take certain steps to tighten and clarify its procedures for making interchangeability determinations. Earlier this year, both…
Today Momenta Pharmaceuticals announced that M923, a biosimilar candidate of AbbVie’s Humira (adalimumab), met the primary endpoint in a Phase III trial of M923 for treatment of patients with…
Below is our Fall 2016 update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or…
On November 21, 2016, Apotex submitted a reply brief in support of its petition for certiorari in Apotex v. Amgen. Previous coverage of Amgen’s opposition is available here. A procedural…
On Thursday, Judge Robinson entered a scheduling order in the AbbVie v. Amgen (adalimumab) case. Among other things, the order sets a 20-day bench trial beginning November 4, 2019. The…
As we previously reported, Amgen and Allergan are currently collaborating on four oncology biosimilars, including an Avastin® (bevacizumab) biosimilar, ABP 215. Yesterday, the companies announced…
On November 8, 2016, Amgen submitted a brief in opposition to Apotex’s petition for certiorari challenging the Federal Circuit’s application of its holding in Amgen v. Sandoz that subsection…
The PTAB has denied institution of inter partes review of Abbvie’s U.S. Patent No. 9,114,166, finding that Petitioner Coherus had not established a reasonable likelihood that it would prevail…
Amgen recently announced that the FDA has approved its supplemental Biologics License Application for the expanded use of Enbrel® (etanercept) to treat pediatric patients (ages 4-17) with chronic…
As we previously reported, Amgen filed an appeal brief challenging the district court’s resolution of its discovery dispute with Hospira and addressing the issue of whether the Federal Circuit…