Last year we reported the FDA approval and then U.S. launch of Inflectra®, a biosimilar of Remicade® (infliximab). This week, Pfizer and Celltrion Healthcare have reported that the results of…
Last year we reported the FDA approval and then U.S. launch of Inflectra®, a biosimilar of Remicade® (infliximab). This week, Pfizer and Celltrion Healthcare have reported that the results of…
The PTAB remains a busy venue for biologics patents. Here are some IPR updates from the weeks since our last IPR update: HERCEPTIN On October 4, the Board instituted IPR…
A recent study evaluated the efficacy, safety, and immunogenicity of switching from reference infliximab (Remicade®, Janssen Biotech), to the biosimilar SB2 (Renflexis®, Samsung Bioepis), in…
On Friday, October 6, Amgen filed a complaint in the Central District of California seeking a declaratory judgment against Genentech that Mvasi® (bevacizumab-awwb), Amgen’s recently…
As we noted earlier today, this week the Federal Circuit is holding oral argument at various venues in New York City. Two of today’s oral arguments were in biosimilar cases…
Last Friday, Samsung Bioepis filed IPR2017-02139 and IPR2017-02140, directed to Genentech’s U.S. Patent No. 6,407,213. According to the petitions, the ‘213 patent claims are directed…
This week, six Federal Circuit panels will hear oral argument on at various venues in New York City. Two of today’s oral arguments are in biosimilar cases that we have…
We previously reported that, according to a May 10, 2017 record on ClinicalTrials.gov, Samsung Bioepis planned to start a Phase 3 clinical trial in September 2017 on SB11, its biosimilar…
The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights: On August 29, Pfizer filed two petitions for IPR…