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.
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
Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart
or our previous quarterly updates (Summer 2016
As we previously reported
, the United States District Court for the District of Massachusetts denied Celltrion’s motion to dismiss
for lack of standing in the Janssen v. Celltrion
case. On November […]
On November 14, 2017, Theradiag, a French company specializing in in vitro
that it had entered into a partnership agreement with Biogen to provide LISA TRACKER kits for monitoring Flixabi
®, Biogen’s […]
We post frequently about citizen petitions
here on the blog. Since the 1970s, the citizen petition process has allowed individual persons or organizations to request that FDA take or not take certain regulatory actions, such […]
We previously reported on Genentech’s complaint
in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents and Amgen’s motion to transfer
that complaint to the Central District of […]
Genentech filed a complaint
last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab). According to the complaint, the FDA accepted Pfizer’s aBLA for review on August […]