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.

Biogen Announces Approval for Biosimilar of Amgen’s Enbrel

Biogen Inc. announced this past Saturday that the European Commission has approved Samsung Bioepis’s proposed biosimilar of Amgen’s Enbrel (etanercept). Enbrel is a biologic drug used to treat five different inflammatory conditions, including rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. This is the first biosimilar of Enbrel approved in Europe….

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AbbVie's Citizen Petition on Interchangeability

On December 16, 2015, AbbVie submitted a Citizen Petition (link) (Docket No. FDA-2015-P-4935) to the FDA concerning the requirements for demonstrating interchangeability between a brand-name reference product and its biosimilar counterpart. In its Citizen Petition, AbbVie requested that the FDA take the following actions: FDA should “ensure that applicants seeking…

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BREAKING NEWS: PTAB Denies IPR Institution on AbbVie’s Humira

The PTAB denied institution on two of Amgen’s IPR petitions (IPR2015-01517, IPR2015-01514) against AbbVie’s Humira.  The patents, 8,916,157 and 8,916,158, are directed to formulations of Humira, that Amgen argued were obvious because they combined adalimumab, a known antibody, with known excipients for antibody formulations.  Based on the PTAB’s claim construction…

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Deal Watch: Mylan & Momenta Collaborate on 6 Biosimilar Medications

On January 8, 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an exclusive global collaboration agreement to jointly develop, manufacture, and commercialize six of Momenta’s current biosimilar medications.  According to public information about the agreement, while each company will equally share costs and profits with respect to the products,…

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