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.

Settlement Reached in Genentech v. JHL Biosimilar Trade Secrets Case

On September 5, JHL Biotech announced that it has reached a settlement agreement with Genentech to resolve the parties’ lawsuit regarding JHL’s alleged misappropriation of trade secrets relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme® (dornase alfa) products. As we previously reported, in October 2018, Genentech filed…

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Biologic Developments in the Treatment of Axial Spondyloarthritis

In August, the American College of Rheumatology released updated guidelines for the treatment of ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA), the two types of axial spondyloarthritis. The new recommendations suggest that patients use TNF inhibitors (Humira, Cimzia and Enbrel) as first-line therapy, followed by IL-17 inhibitors (Cosentyx and Taltz)…

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DEAL WATCH: Recent Biosimilar Collaboration Announcements

In recent weeks, several drug makers announced collaborations for the development, manufacture, and/or commercialization of a variety of biosimilars or follow-on biologics.  Below are some highlights: On September 3, 2019, Polpharma Biologics and Sandoz announced that they have entered into a global commercialization agreement in connection with Polpharma’s proposed biosimilar…

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Accord BioPharma substituted for Apotex as party in filgrastim/pegfilgrastim biosimilar litigation

As we previously reported, the parties in the follow-on Amgen v. Apotex BPCIA litigation concerning Apotex’s proposed biosimilars of NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) informed the district court on August 8 that they were drafting a stipulation and unopposed motion that would substitute Apotex as a party with a then-unnamed…

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Federal Circuit Upholds Ruling in Favor of Sandoz in Filgrastim/Pegfilgrastim Biosimilar Appeal

This past May, in the Amgen v. Sandoz BPCIA litigation concerning Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and proposed pegfilgrastim biosimilar, a Federal Circuit panel affirmed the district court’s judgment of non-infringement in favor of Sandoz. The panel found that Amgen could not prevail on its infringement claims under the doctrine of…

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Amgen and Allergan Announce Positive Results from Clinical Study of Rituxan Biosimilar Candidate

On August 22, Amgen and Allergan announced positive top-line results from a clinical study (JASMINE) comparing the efficacy and safety of the biosimilar candidate ABP 798 (rituximab) to the reference drug Rituxan® in patients with CD20-positive B-cell non-Hodgkins lymphoma. As we reported in January, ABP 798 was previously found to…

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FTC Issues Civil Investigative Demand to Johnson & Johnson Regarding Remicade

We have covered Pfizer’s antitrust suit against Johnson & Johnson, the manufacturer of REMICADE (infliximab), as well as a related antitrust litigation filed by retailers Walgreen and Kroger Co. and direct and indirect purchasers of Remicade.  The cases generally allege that Johnson & Johnson excluded Pfizer’s infliximab biosimilar from the market through anticompetitive…

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United Healthcare and OneOncology Update Preferred Products to Include Biosimilars

United Healthcare and OneOncology have added Amgen’s MVASI (bevacizumab-awwb) and KANJINTI (trastuzumab-anns), biosimilars to AVASTIN and HERCEPTIN respectively, as preferred products, according to literature released by those providers. United Healthcare released a bulletin indicating that, as of October 1, 2019, United Healthcare will update its preferred product language to reflect…

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