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.

Federal Circuit Certifies AbbVie's Constitutional Challenge in Consolidated Adalimumab IPR Appeals to U.S. Attorney General

As we previously reported, currently pending before the Federal Circuit are consolidated appeals from five final written decisions of the Patent Trial and Appeal Board (Board) in inter partes review (IPR) proceedings finding the claims of AbbVie’s U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987 unpatentable for obviousness in view of…

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Post-Trial Briefing on Invalidity in Immunex v. Sandoz Etanercept Litigation

On September 25, 2018, the 10-day bench trial came to an end in the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar.  As we previously reported, prior to the start of trial, the Court had entered a stipulation of infringement of certain asserted claims of U.S. Patent No. 8,063,182 (“the ‘182 patent”)…

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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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