Welcome to the Big Molecule Watch!


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.

Genentech Beats Off-Label Use Lawsuit for Avastin

In a decision that could have implications for biosimilar drug manufacturers whose products are used for off-label uses, on October 30, 2015, Texas judge Michael Mery threw out strict liability, implied warranty, and negligence claims brought by plaintiff Robert Burt against Genentech Inc. and Genetech USA, Inc. The complaint alleged…

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NHS Releases Biosimilars Guidance, Prohibits Automatic Substitution

On September 24, 2015, the United Kingdom’s National Health Service (NHS) released a biosimilars guidance document, available here. In it, the NHS bans automatic substitution of biosimilars, meaning that pharmacists may not switch between biosimilars and reference biologics, or between one biosimilar and another, without the consent of the prescribing…

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FDA Rejects Hospira's Epogen Biosimilar

Last year, Hospira, Inc. (owned by Pfizer, Inc.) submitted an abbreviated Biologics License Application (aBLA) for its proposed biosimilar to Amgen’s Epogen (epoetin alfa).  The biosimilar has been available in Europe since 2008  – under the name of Retacrit – for the treatment of anemia associated with chronic renal failure.  On its quarterly…

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