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.
In October, a Federal Circuit panel vacated
a permanent injunction
(which the Federal Circuit had earlier stayed
pending appeal) that would have otherwise prohibited
the sale of Sanofi and Regeneron’s Praluent® […]
Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions
) and Pfizer’s
As we previously reported
, Janssen and Samsung Bioepis jointly filed a stipulation of voluntary dismissal requesting that the District of New Jersey dismiss with prejudice Janssen’s patent infringement claims against Samsung Bioepis based on Samsung Bioepis’s […]
On Friday, Biocon and Mylan announced
that the European Medicines Agency has accepted applications for their proposed trastuzumab and pegfilgrastim biosimilars. As we previously reported
, Biocon had earlier requested withdrawal and resubmission of these […]
Today, the FDA announced
that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab). Ogivri is indicated for adjuvant treatment of breast cancer and treatment of metastatic breast […]
Next Tuesday (December 5) between 1:00-2:30pm (EST), FDA’s Division of Drug Information is presenting a webinar titled an “Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.” The […]
As we previously reported
, Amgen and Hospira both filed motions asking the Court to partially set aside the jury verdict
in the Amgen v. Hospira litigation. In its motion
, Hospira […]
We previously posted that Coherus had filed a motion to stay
discovery in Amgen v. Coherus (involving pegfilgrastim) pending resolution of Coherus’s motion to dismiss. On September 13, Coherus withdrew
Biocon Ltd., a biopharmaceutical company based in India, develops, manufactures and supplies products to treat diabetes, cancer, and autoimmune conditions. Last week
, Biocon launched KRABEVA®, a bevacizumab biosimilar for the treatment of metastatic colorectal […]
The Supreme Court today considered
the constitutionality of the IPR statute in a lively hour-long oral argument before a packed courtroom. The case, Oil States Energy Services, LLC v. Greene’s Energy Group, LLC