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.

Insulin Biosimilars Update

Some noteworthy regulatory and litigation events related to insulin biosimilars have occurred recently. On May 13, 2019, FDA held a public hearing entitled “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products” at FDA’s White Oak campus in Silver Spring, Maryland. …

Read More

AbbVie and Boehringer Ingelheim Settle Adalimumab Biosimilar Patent Disputes

Today, AbbVie and Boehringer Ingelheim (“BI”) announced that they reached a resolution of all intellectual property-related litigation concerning BI’s proposed biosimilar Cyltezo® (adalimumab-adbm).  According to the press releases, AbbVie has granted BI a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States.  All U.S. litigation pending between the parties…

Read More

BREAKING NEWS: Federal Circuit Affirms Sandoz’s Victory Over Amgen in Filgrastim and Pegfilgrastim Biosimilar Patent Litigation

This morning, the Federal Circuit issued a precedential opinion affirming the district court’s judgment of non-infringement in favor of Sandoz in its BPCIA litigation against Amgen concerning Sandoz’s Zarxio® (filgrastim-sndz) biosimilar product and proposed pegfilgrastim biosimilar.  As we previously reported, in December 2017 the Northern California district court granted summary…

Read More

Taiwan-based EirGenix and Sandoz Partner to Commercialize EirGenix’s Trastuzumab Biosimilar

Taiwan-based EirGenix, Inc. and Sandoz recently announced that they have entered into an agreement, giving Sandoz an exclusive license to commercialize EirGenix’s proposed biosimilar version of Roche’s Herceptin (trastuzumab), which is now in in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) breast…

Read More

US DOJ Urges Striking Down Entire ACA

As previously reported, in December 2018, the District Court for the Northern District of Texas in Texas v. United States issued an order declaring that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, that the remaining provisions of the ACA are not severable from the mandate provision,…

Read More

Samsung Bioepis Sued Regarding Its Recently-Approved Etanercept Biosimilar

Yesterday, Immunex, Amgen, and Hoffmann-LaRoche (collectively, “Plaintiffs”) filed a complaint in the District of New Jersey against Samsung Bioepis alleging patent infringement under the BPCIA based on Samsung Bioepis’ submission of an aBLA for a biosimilar of ENBREL® (etanercept).  As we reported yesterday, Samsung Bioepis recently received FDA-approval for that product,…

Read More