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.
Read More

Federal Circuit Oral Arguments in NYC today: A Review

Amgen v. Apotex (pegfilgrastim)  •  Biologics Litigation  •  BPCIA and Related U.S. Statutes  •  Janssen v. Celltrion (infliximab)  •  Patent Dance  •  U.S. Biosimilar Litigation News
As we noted earlier today, this week the Federal Circuit is holding oral argument at various venues in New York City. Two of today’s oral arguments were in biosimilar cases that we have been closely […]

View More

Amgen and AbbVie Settle Adalimumab BPCIA Litigation

AbbVie v. Amgen (adalimumab)  •  AbbVie v. Boehringer Ingelheim (adalimumab)  •  Approved Biosimilar Products  •  Biologics Litigation  •  Biosimilar News  •  U.S. Biosimilar Litigation News
Amgen has announced that it has settled all pending patent litigation regarding AMJEVITA, its biosimilar version of AbbVie’s Humira® (adalimumab). Amgen reports that AbbVie will grant patent licenses for the use and sale […]

View More