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.
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Summary of Sandoz’s Response and Reply Brief in Sandoz v. Amgen

Amgen v. Sandoz (filgrastim)  •  Biologics Litigation  •  BPCIA and Related U.S. Statutes  •  Patent Dance  •  U.S. Biosimilar Litigation News
On March 31, Sandoz filed its consolidated response and reply brief in Sandoz v. Amgen. We have previously covered Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief.  Amgen’s final reply brief was filed […]

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