As we previously reported, on June 4, 2018, the U.S. FDA approved Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) as the first biosimilar of Neulasta® to obtain approval in the…
As we previously reported, on June 4, 2018, the U.S. FDA approved Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) as the first biosimilar of Neulasta® to obtain approval in the…
On July 20, 2018, Pfizer issued a press release reporting that the U.S. FDA has approved Nivestym™ (filgrastim-aafi), Pfizer’s proposed biosimilar of Neupogen®, for all eligible indications…
Today, Amgen filed a complaint for patent infringement under the BPCIA against Hospira and its parent Pfizer concerning their proposed biosimilar of Neupogen® (filgrastim). According to the…
This morning AbbVie announced that it has entered into patent license agreements with Mylan over its proposed biosimilar of Humira® (adalimumab). AbbVie states that it has agreed to “grant Mylan…
Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3…
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from…
Pending U.S. District Court BPCIA Litigations Aflibercept+ Regeneron v. Amgen Inc., 2-24-cv-00264 (C.D. Cal.) (transferred to N.D. W.Va., C.A. 1:24-cv-00039) Accused Biosimilar: PAVBLU…
As we previously reported, the district court granted Sandoz’s motion for summary judgment of non-infringement in the ongoing Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and…
Today, we’re catching up with news from around the industry. Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710. According to…
United States Senators Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) recently sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the “FTC to examine global…