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 Commission Grants Marketing Authorization for Adalimumab and Trastuzumab Biosimilars

Last week the European Commission granted marketing authorization for two biosimilars. First, Sandoz, a division of Novartis, announced on July 27 that it had received marketing authorization for Hyrimoz, its adalimumab biosimilar to AbbVie’s Humira.  Authorization was granted for all indications of the reference biologic, including rheumatoid arthritis, plaque psoriasis,…

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Biosimilar Litigation Updates

Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of non-infringement in favor of Sandoz in the Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen filed…

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Breaking News Update – Janssen v. Celltrion: District Court Rules in Favor of Celltrion on Summary Judgment of Non-Infringement

Today, Judge Wolf found in favor of Celltrion, granting its motion for summary judgment of non-infringement of the sole remaining patent-in-suit based on an application of the ensnarement doctrine to Janssen’s infringement theory under the doctrine of equivalents.  The Court determined that Celltrion’s infliximab biosimilar does not infringe Janssen’s ’083…

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FDA Biosimilars Labeling Guidance

Recently, the FDA released industry guidance regarding biosimilar product labeling, which is entitled “Labeling for Biosimilar Products” (“Biosimilars Labeling Guidance”).  The Biosimilars Labeling Guidance provides recommendations for biosimilar product labeling, specifically for the proposed package insert, and is intended to help applicants in drafting labels for an aBLA. Some highlights…

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Congressman Sarbanes Introduces Bill to Curb "Pay-For-Delay" Agreements - UPDATED with Proposed Legislation

On July 23, 2018, Congressman John Sarbanes (D-Md.) introduced a bipartisan bill, the Biosimilars Competition Act of 2018, meant to curb “pay-for-delay” agreements entered into by biologic and biosimilar drug manufacturers.  According to Congressman Sarbanes, the purpose of the bill is to help lower the cost of prescription drugs by affirmatively giving…

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