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.
The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER
.” The guidance is intended to clarify the circumstances where the CDER (Center for Drug Evaluation and […]
The FDA granted final approval
of Sanofi’s 505(b)(2) application for Admelog yesterday. According to the FDA, Admelog is a follow-on product that, for approval, relied in part on FDA’s finding of safety and effectiveness of Eli Lilly’s […]
We have been following the Delaware Amgen v. Coherus
(pegfilgrastim case). In response to Amgen’s Complaint
, Coherus filed a motion to dismiss the entire suit
arguing that Amgen’s Complaint failed […]
On December 5, 2017, the Federal Circuit heard oral argument in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company
, 17-1694. Momenta is appealing a PTAB decision upholding the validity of BMS’s U.S. Patent No. 8,476,239 (“the ’239 patent”) which […]
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 […]