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.
Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand
proceedings for Amgen v. Sandoz
, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s disclosure […]
Goodwin’s Intellectual Property
and Life Sciences
teams won three awards, and were shortlisted in 10 categories for over 10 awards, at the 2017 LMG Life Sciences Awards hosted in New York City on […]
As we previously reported
, last month AbbVie filed a
complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira (adalimumab) product. Yesterday, BI filed […]
Today, the FDA announced
that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of cancer. Mvasi® […]
This morning, the district court in Janssen v. Samsung Bioepis
, which concerns Samsung Bioepis’ Renflexis®
(infliximab-abda) biosimilar product, entered a pretrial scheduling order
. The scheduling order calls for, among other things, […]
At the European Society for Medical Oncology (“ESMO”) 2017 Congress
, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of Herceptin (trastuzumab). First, […]
According to press releases this week, the FDA has recently accepted two new Abbreviated Biologics License Applications (aBLA) for review. First, Adello Biologics yesterday announced
that the FDA has accepted its aBLA for its […]
Yesterday, in the remanded appeal
in Amgen v. Sandoz
, the United States submitted an amicus brief
to the Federal Circuit that generally supports the position taken by Sandoz
and the […]
With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira
last week denied
Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit® (epoetin […]
Last week Fresenius Kabi announced that it has successfully closed its acquisition of Merck KGaA’s biosimilars business, which comprises Merck’s entire biosimilars development pipeline. According to Fresenius, the product pipeline is focused on oncology and autoimmune […]