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.

AbbVie and Fresenius Kabi Settle Adalimumab Biosimilar Patent Disputes

Abbvie and Fresenius Kabi have announced today that they entered into a worldwide settlement and licensing arrangement resolving all intellectual property-related litigation concerning Fresenius’s MSB11022, a biosimilar candidate of AbbVie’s HUMIRA (adalimumab). According to the press releases, under the terms of the royalty-bearing settlement and license agreements, AbbVie has granted…

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President Signs Bill Requiring FTC and DOJ Review of Biosimilar Patent Litigation Settlements

Following up on our prior reports, last week President Trump signed into law the “Patient Right to Know Drug Prices Act” (S.2554).  Among other changes, the bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require that Reference Product Sponsors and biosimilar applicants file patent settlement agreements…

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Biosimilar Pipeline Update

Below are some recent announcements from Momenta Pharmaceuticals, Fresenius Kabi, JHL Biotech, and Innovent Biologics regarding their biosimilar pipelines. On October 1, 2018, Momenta Pharmaceuticals announced that it completed a strategic review of its pipeline with the goal of reducing costs of biosimilar development and focusing its resources on its…

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AbbVie and Sandoz Settle Adalimumab Biosimilar Patent Disputes

On October 11, 2018, AbbVie and Sandoz announced that they reached a global resolution of all intellectual property-related litigation concerning Sandoz’s Hyrimoz™, a proposed biosimilar of Humira® (adalimumab).  According to the press releases, under the terms of the royalty-bearing settlement agreements, AbbVie is granting to Sandoz a non-exclusive license to…

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Hospira Appeals $80 Million Judgment in Epoetin Alfa Biosimilar Case

As we reported, last month in the Amgen v. Hospira litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, the Delaware district court entered final judgment against Hospira, awarding Amgen $70 million in damages and approximately $10 million in pre-judgment interest, plus post-judgment interest in an amount to be determined at a…

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ODAC Votes in Favor of Biosimilarity of Celltrion's CT-P10

As reported here, the Oncologic Drug Advisory Committee (ODAC) held a public hearing today at the U.S. Food & Drug Administration to discuss and vote on Celltrion’s Biologics License Application for CT-P10, a proposed biosimilar of Genentech’s U.S.-licensed rituximab product Rituxan.   The hearing included presentations from various speakers from industry,…

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