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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MYLAN, APOTEX, COHERUS, AND ADELLO FILE AMICUS BRIEFS IN SANDOZ V. AMGEN

Amgen v. Sandoz (filgrastim)  •  Patent Dance  •  U.S. Biosimilar Litigation News  •  U.S. Supreme Court Decisions
SupremeCtExterior_457419987 As we covered in previous posts, the Supreme Court will hear arguments regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions in April 2017.  Several amicus briefs in support […]

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