Welcome to the Big Molecule Watch!

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Goodwin’s award-winning Big Molecule Watch is the best resource for daily updates and analyses of regulatory issues, litigation, legislation, and other news in the world of biologics, biosimilars and related technologies. The editors of this blog have collectively been watching and engaging with the world of biologics and biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S.  With extensive experience representing clients at all stages of a biologic’s or biosimilar’s lifecycle, from research and development, to patents, to regulatory application and approval, and through litigation and appeals, we are excited to share our observations and insights as the industry and the law continues to develop in this exciting area.

This blog focuses on “big molecules” as opposed to “small molecules.” Small molecule drugs have low molecular weight, a simple and well-defined structure, and are chemically synthesized. In contrast, “big molecule” drugs have high molecular weight, complex structures, and are derived from living organisms. For example, aspirin is small molecule while a monoclonal antibody is a big molecule. For further reading on big molecules, consider FDA's resources on biologics.

BPCIA Litigation Roundup (Fall 2017)

Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017, Summer 2017).

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Theradiag Partners with Biogen on Infliximab Monitoring Kits

On November 14, 2017, Theradiag, a French company specializing in in vitro diagnostics, announced that it had entered into a partnership agreement with Biogen to provide LISA TRACKER kits for monitoring  Flixabi®, Biogen’s infliximab biosimilar that is marketed in Europe.  Theradiag’s LISA TRACKER kits allow clinicians to monitor trough plasma…

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Article Regarding Citizen Petitions

We post frequently about citizen petitions here on the blog.  Since the 1970s, the citizen petition process has allowed individual persons or organizations to request that FDA take or not take certain regulatory actions, such as not approving pending new drug applications.  In recent years, the citizen petition process has come…

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Amgen Files Reply in Support of Motion to Transfer Bevacizumab Action to California

We previously reported on Genentech’s complaint in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents and Amgen’s motion to transfer that complaint to the Central District of California.  Today Amgen filed its reply (redacted) in support of transfer.  In its reply, Amgen addresses Genentech’s…

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Genentech Files Complaint Against Pfizer Regarding Herceptin

Genentech filed a complaint last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab).  According to the complaint, the FDA accepted Pfizer’s aBLA for review on August 21, 2017. Genentech’s complaint acknowledges that the parties had started, but not completed, the information exchanges of the…

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IPR Updates

Here are some updates since our last IPR update: HUMIRA On November 6, 2017, Sandoz filed an IPR Petition challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156).  The ‘559 patent is directed to a method for treating idiopathic inflammatory bowel disease. RITUXAN On November 6, 2017, the Board denied institution of an IPR on Pfizer’s…

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Sandoz Announces New Data For Its Adalimumab And Rituximab Biosimilars

On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®.  We previously reported that the Sandoz adalimumab biosimilar is currently under EMA review.  As we reported here, the Sandoz rituximab biosimilar has been approved by the European Commission…

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