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

BPCIA Litigation Roundup (Summer 2017)

AbbVie v. Amgen (adalimumab)  •  AbbVie v. Boehringer Ingelheim (adalimumab)  •  Amgen v. Apotex (pegfilgrastim)  •  Amgen v. Coherus (pegfilgrastim)  •  Amgen v. Hospira (epoetin alfa)  •  Amgen v. Sandoz (filgrastim)  •  Amgen v. Sandoz (pegfilgrastim)  •  Genentech v. Amgen (bevacizumab)  •  Immunex v. Sandoz (etanercept)  •  Janssen v. Celltrion (infliximab)  •  Janssen v. Samsung Bioepis (infliximab)  •  U.S. Biosimilar Litigation News
Below is our summer 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, […]

View More

Amgen v. Sandoz Appeal: Parties Submit Supplemental Briefing; Court Grants US Extension to File Amicus Brief

Amgen v. Sandoz (filgrastim)  •  Biologics Litigation  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  U.S. Biosimilar Litigation News
As we previously reported, following the Supreme Court’s June 12, 2017 decision in Sandoz v. Amgen,  the Federal Circuit on July 26, 2017, issued an order recalling its October 23, […]

View More