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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Janssen v. Celltrion: Janssen Appeals Judgment Invalidating the ’471 Patent

Approved Biosimilar Products  •  Janssen v. Celltrion (infliximab)  •  U.S. Biosimilar Litigation News  •  U.S. District Court Decisions
Deal Watch 2 As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid.  Today, Janssen filed a notice that they are 

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Biosimilars Council Files Amicus Brief in support of Apotex’s Petition for Certiorari in Amgen v. Apotex

Amgen v. Apotex (pegfilgrastim)  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  U.S. Biosimilar Litigation News  •  U.S. Federal Circuit Decisions
174260390_250x170 As we covered in a previous post, Apotex has filed a cert. petition asking the Supreme Court to review  the Federal Circuit’s ruling on the BPCIA’s notice provision in Amgen v. Apotex.  Last […]

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