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
, 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 14, […]
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 21, […]
We previously reported
on Amgen’s complaint in the Central District of California seeking a declaratory judgment that 27 Genentech patents are not infringed by Genentech’s bevacizumab biosimilar (Mvasi®). On November 15, 2017, […]
Samsung Bioepis announced
today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European Economic Area member […]
Here are some updates since our last IPR update: HUMIRA On November 6, 2017, Sandoz filed an IPR Petition
challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156). The ‘559 patent is directed to a […]
On November 14, 2017, Sandoz announced
data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®. We previously reported
that the Sandoz adalimumab biosimilar is […]
Last week, FDA Commissioner Scott Gottlieb announced
new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance
provides for a single shared Drug Master File submission for all […]