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.

European Medicines Agency Recommends Market Authorization for First Etanercept Biosimilar

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal products for Human Use (CHMP) recommended the granting of a market authorization for Benepali, a biosimilar intended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.  This is the second biosimilar antibody drug that…

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Amgen Submits Application for Biosimilar Version of Humira (adalimumab)

Amgen today announced the submission of its first biosimilar application to FDA. The application seeks approval for a biosimilar version of Humira®(adalimumab). As we’ve covered extensively, Amgen is the biologic reference product sponsor and plaintiff in a number of BPCIA cases: Amgen v. Sandoz, Amgen v. Hospira, and Amgen v. Apotex.  This is the first time Amgen has formally appeared on…

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Roundup of Upcoming BPCIA Cases

As we have written about extensively, here, here, and here, the Federal Circuit recently interpreted two key provisions of the BPCIA in Amgen v. Sandoz. Three cases currently pending before District Courts raise related issues and each have the potential to reach the Federal Circuit. In this post, we provide…

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Apotex opposes Amgen’s motion for PI

On Friday, November 16, 2015, Apotex filed its brief in opposition to Amgen’s motion for a preliminary injunction in Amgen v. Apotex.  As we’ve discussed previously here, Amgen has moved to enjoin Apotex from marketing its yet-to-be-approved Neulasta biosimilar until at least 180 days after FDA approval.  Amgen has taken…

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Supplemental Scheduling Order Issued In Amgen v. Apotex

Yesterday Judge Cohn issued a supplemental scheduling order in Amgen v. Apotex.  The hearing for Amgen’s Motion for Preliminary Injunction has been rescheduled for December 3, 2015.  Claim construction briefing will occur in December and January, and the claim construction hearing will be held on February 5, 2016.  Expert reports…

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