Welcome to the Big Molecule Watch!

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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.

Filgrastim PTAB Update

As we previously reported, earlier this year Kashiv Biosciences filed two inter partes review (IPR) petitions challenging certain claims of Amgen’s U.S. Patent Nos. 8,940,878 and 9,643,997, which are directed to methods to purify proteins expressed in a non-native soluble form in a non-mammalian expression system.  Amgen is asserting the ’878 and…

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Amneal, Amgen, and Kashiv jointly stipulate to dismiss patent in filgrastim litigation

As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a protein refolding process. In their answer, Adello sought a declaratory judgment that certain claims of the ’138 patent were not infringed…

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Biosimilar Development Update: Mochida, Celltrion, Innovent, DRL, Fresenius

Below are some highlights of recent biosimilar development news from this week:   On September 20, Mochida announced that it had obtained marketing approval in Japan for RGB-10, a biosimilar of FORTEO (teraparitide) that Mochida developed in Japan based on a comprehensive license and collaboration agreement with Gedeon Richter Plc. …

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Biosimilar Development Updates

Below are some recent highlights of biosimilar news: On August 20th, two companies announced that they had launched competing biosimilars of Eli Lilly’s FORSTEO (teriparatide) in Europe.  First, Gedeon Richter announced that it launched TERROSA in Europe after it received approval from the European Commission.  According to the announcement, the…

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