Welcome to the Big Molecule Watch!
Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.
If you’re looking for a primer on biologics, check out our background post
introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).
We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.
Yesterday, in Ericsson Inc. v. Regents of the University of Minnesota
, an expanded 7-judge PTAB panel ruled
that a patent owner waives a claim to sovereign immunity in an IPR “by […]
On December 16, Celltrion announced
that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Herzuma, its trastuzumab biosimilar. The […]
As we previously reported
, in Amgen v. Sandoz
, which relates to both Sandoz’s filgrastim biosimilar (Zarxio) and its pegfilgrastim biosimilar, Sandoz had filed motions for summary judgment regarding non-infringement of Amgen’s ‘878 patent — […]
Fresenius Kabi today announced
it has submitted an application seeking marketing authorization for its biosimilar version of Humira® (adalimumab) in the EU. This is Fresenius Kabi’s first biosimilar regulatory filing.
Below are IPR updates from this week. LANTUS On December 13, 2017, the Board instituted two IPRs on Mylan’s petitions (IPR2017-01526
) challenging Sanofi’s U.S. Patent Nos. 7,713,930 and 7,476,652, respectively, […]
, the Federal Circuit Court of Appeals issued its long-awaited decision
in the remand of Amgen v.
Sandoz from the U.S. Supreme Court. In that decision, the Federal Circuit held that Amgen’s state law […]
On December 8, 2017, Sandoz, a division of Novartis, announced data purportedly showing that its pegfilgrastim biosimilar candidate matches the reference biologic, Neulasta® in terms of pharmacokinetics, pharmacodynamics, safety and immunogenicity profiles. The data were presented […]
The Federal Circuit today ruled
decisively in favor of Sandoz in the long-running battle with Amgen over whether state law can be used to compel a biosimilar applicant to participate in the BPCIA’s […]
Today, the FDA announced that it has approved Pfizer’s Ixifi® (infliximab-qbtx) as a biosimilar to Remicade®. Ixifi® is indicated
for the treatment of most of the same conditions as its reference product: Crohn’s […]