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.

GABI Publishes Data on Italian Biosimilar Landscape

A paper published in the Generics and Biosimilars Initiative Journal reports on “an overview of the available real-world data about the pattern of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy.” The paper, which was based on studies funded by the Italian Ministry of Health,…

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Federal Circuit Affirms Dismissal of AbbVie's Humira License Suit

The Federal Circuit has ruled that AbbVie’s declaratory judgment action seeking to invalidate a patent licensed from MedImmune will not go forward. AbbVie licensed several patents stemming from a research collaboration that produced adalimumab, the active ingredient in Humira. The license provides for royalties until the later of expiry of the…

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Sanofi/Regeneron Move for Summary Judgment of Invalidity in Dupixent® Patent Litigation

Last week, in the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, the Defendants moved for summary judgment of invalidity of the sole patent-in-suit, the ‘487 patent, on the ground that the patent’s claims are indefinite. According to Defendants’ brief,…

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Recommendatoins For The Use Of Biosimilars To Treat Rheumatological Diseases

The February edition of the Annals of the Rheumatic Diseases published a Recommendation titled, “Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases.” A panel of rheumatologists, dermatologists, gastroenterologists, and pharmacologists, as well as patients and regulators, were assembled to conduct a study aimed at developing recommendations regarding…

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Pipeline Updates from Clover, Pfizer, and Mylan/Biocon

Clover Biopharmaceuticals, a clinical-stage biotech company based in Chengdu, China, and General Electric announced last week that Clover had selected General Electric’s FlexFactory biomanufacturing platform for Clover’s new manufacturing facility, to be located in the Changxing Economic and Technological Development Zone.  The facility, which is scheduled to open in the second half of 2018, will feature…

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Sandoz announces collaboration with Biocon on next-generation biosimilars

Last week, Sandoz announced a new collaboration with Asian biopharmaceutical company Biocon to “to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of…

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New BPCIA Litigations Regarding Celltrion's Trastuzumab and Rituximab Biosimilars

On January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District Court for the Northern District of California.  Case No. 3:18-cv-00274 relates to Celltrion’s Herzuma®, its trastuzumab biosimilar. According to the complaint, Celltrion and Teva seek a declaratory judgment of non-infringement, invalidity, and/or unenforceability of 38…

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