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.

Biologics IPR Updates

Last week, the Patent Trial and Appeal Board (“Board”) denied institution of four IPR petitions on biologics-related patents.  First, the Board denied institution of IPR2017-01987 and IPR2017-01988, both filed by Sandoz Inc.  These IPRs sought to challenge U.S. Patent Nos. 8,911,737 and 8,974,790, respectively, both owned by AbbVie Biotechnology Ltd., and…

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Biologics Provisions Suspended in Signed CPTPP

We previously reported on the announced agreement to enter into the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). As previously announced, the final version of the CPTPP suspended all of the biologics provisions (Article 18.51) that appeared in the TPP.  According to past reports, the biologics provisions were heavily…

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FDA Commissioner Gottlieb Gives Speech on Biosimilars

Earlier today, FDA Commissioner Scott Gottlieb, MD, gave a speech focusing on biosimilars at America’s Health Insurance Plans’ National Health Policy Conference in Washington, D.C.  In his speech, Commissioner Gottlieb highlighted a 2017 study by QuintilesIMS that observed significant cost savings and dramatically expanding patient access in the EU from biosimilars…

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Trastuzumab IPR Updates

Last month, the PTAB issued decisions on two petitions, IPR2017-02063 and IPR2018-00016, filed by Pfizer against one of Genentech’s Herceptin® (trastuzumab) patents, U.S. Patent No. 7,846,441 (“the ‘441 patent”). The ‘441 patent has claims directed to methods of treating a malignant progressing tumor or cancer characterized by overexpression of ERBB2 receptor. IPR2017-02063…

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Update on biosimilar launches and development

gloved hand withdraws drug solution with syringe

Sources are reporting that Korean pharmaceutical company Daewoong Pharmaceutical announced today that it has launched Samfenet, a biosimilar to Roche’s HERCEPTIN® (trastuzumab), in Korea.  Samfenet is priced at a 29.5-percent discount to Herceptin, which amassed around $6.5 billion in global revenue last year. Mylan announced last week that it has…

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South Dakota Passes Automatic Substitution Law for Interchangeable Biosimilars

South Dakota passed a law that allows pharmacists to automatically substitute a biosimilar for a prescribed biological product.  According to the new law, which was signed by South Dakota’s governor on February 12, 2018, the biosimilar must be “interchangeable” with the prescribed biological product under 42 U.S.C. § 262(k)(4) to qualify…

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