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.

Judge Sets Preliminary Injunction Briefing Schedule in Genentech v. Sandoz

We previously reported that on December 21, 2017, Genentech filed suit against Sandoz in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013.  On April 23, 2018, Judge Renee Marie Bumb held an in-person status conference and set forth a preliminary injunction briefing schedule.  The Court ordered the motion for preliminary…

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PTO Issues Guidance in Wake of SAS Decision

As we reported earlier this week, the Supreme Court held in SAS Institute Inc. v. Iancu that when the PTAB institutes an IPR, it must decide the patentability of all challenged claims.  The U.S. Patent and Trademark Office yesterday issued guidance on the impact of SAS.  The guidance explains that going forward: …

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Court Grants Amgen’s Motion To Dismiss Genentech’s Declaratory Judgment Counts in Mvasi™ Litigation, and Sets June 2020 Trial Date

We previously reported that in the ongoing Genentech v. Amgen litigation regarding Amgen’s proposed bevacizumab biosimilar, Mvasi™, Amgen moved to dismiss Genentech’s declaratory judgement counts relating to when Amgen could begin commercial marketing of its product.  In particular, Genentech had sought a judgment that Amgen could not market its product…

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AbbVie Reports Positive Phase 3 Results Showing Small Molecule Upadacitinib Is Superior To Adalimumab For RA

AbbVie recently announced positive results for upadacitinib, a small molecule Janus Kinase (JAK) inhibitor, in a phase 3 clinical trial of patients with rheumatoid arthritis (RA). According to AbbVie, upadacitinib met all primary and secondary endpoints in the study, including superiority versus adalimumab, the anti-TNFα antibody that Abbvie markets as…

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