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.

Merck Transfers Biosimilars and Other Products to Spinoff Company

Last week, Merck announced its intention to spin-off products from its Women’s Health, legacy brands, and biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company.  According to Merck, “NewCo will pursue global leadership and focused, sustainable growth in Women’s Health led by the growing and patent-protected NEXPLANON (etonogestrel implant)…

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FDA Issues Draft Guidance On Biosimilar Licensure For Fewer Than All Conditions Licensed for Reference Product

The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”  In this guidance, the FDA addresses the following issues: Submission of an application seeking licensure of a proposed biosimilar or proposed interchangeable…

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Biosimilars Update: Bio-Thera Solutions BAT1706 (bevacizumab) and Pfizer RUXIENCE (rituximab)

Below are a few biosimilar-related updates from the past week. Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer.”  Bio-Thera indicated that…

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FDA’s Draft Guidance on Promotional Labeling and Advertising Considerations

Earlier this week FDA issued a draft guidance on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products.” The draft guidance addresses the truthful and non-misleading manner in which data and information concerning reference or biosimilar products must be presented. The draft guidance does not address issues…

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