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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Bristol Myers Squibb, Bavarian Nordic, and Enzo Biochem file amicus brief supporting Amgen’s petition for en banc consideration of written description and enablement issues in Praluent® litigation

Biologics Litigation  •  U.S. Federal Circuit Decisions
As we reported previously, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanding the […]

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