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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BPCIA Litigation Roundup (Spring 2017)

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

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FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT® Biosimilar

Amgen v. Hospira (epoetin alfa)  •  Approved Biosimilar Products  •  Biosimilar News
As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa).  Pfizer, Hospira’s parent company, has announced today […]

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