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.

Update on the Amgen v. Adello Filgrastim Litigation

On April 15, 2019, the parties filed their opening claim construction briefs (Amgen’s Brief; Adello’s Brief) in the Amgen v. Adello BPCIA litigation concerning Adello’s aBLA for a biosimilar of Neupogen® (filgrastim).  The patents at issue are U.S. Patent Nos. 8,940,878; 9,643,997; 8,952,138; and 9,856,287, each generally directed to the production of proteins in…

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Eculizumab Biosimilar Approved in Russia

Alexion’s Soliris® (eculizumab) is a monoclonal antibody for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Soliris® has already been approved in the U.S., EU, and Japan as a first line treatment. Last week, Russia approved the launch of an eculizumab biosimilar developed by Generium,…

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Sandoz Resubmits Its Biosimilar Pegfilgrastim Application

Last week, Sandoz announced the resubmission of its Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim).  The resubmission is to address an FDA complete response letter that Sandoz received in June 2016.  According to the press release, the resubmission includes new data from a pivotal pharmacokinetics/pharmacodynamics study.  The study compared: …

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District Court Denies Apotex’s Motion to Dismiss Amgen’s Complaint in Second Lawsuit

Last week, the district court in Amgen v. Apotex (No. 18-61828) (S.D. Fla.) denied Apotex’s motion to dismiss Amgen’s complaint in a follow-on suit concerning Apotex’s pegfilgrastim and filgrastim biosimilar candidates. By way of background, Amgen and Apotex have been involved in multiple patent lawsuits regarding Apotex’s pegfilgrastim and filgrastim biosimilars…

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FDA to Hold Hearing Concerning Insulin Costs

The FDA has announced that it will hold a hearing to discuss affordability of and access to insulin products, including issues concerning the development of biosimilar and interchangeable insulin products.  The hearing will cover scientific standards for evaluating biosimilarity and interchangeability of insulin products; other regulatory considerations, such as whether…

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