In a June 12, 2017 decision authored by Justice Clarence Thomas, the United States Supreme Court in Sandoz v. Amgen ruled that, under the Biologics Price Competition and Innovation Act (BPCIA), biosimilar makers can give notice of commercial marketing before the United States Food and Drug Administration (FDA) licenses their biosimilar products.  The Sandoz ruling resolves an ambiguity in the text of the BPCIA, which gave rise to a presumption by some (and a holding by the Federal Circuit at 794 F.3d 1347, 1358 (2015)) that biosimilar makers had to wait until 180 days after FDA licensure of their biosimilar products before providing notice of the commercial marketing of those products—thereby potentially extending by an additional six months the BPCIA’s statutory 12-year exclusivity period for innovator biologics.  The Sandoz ruling makes clear that an additional six-month period of exclusivity was not contemplated by the BPCIA.

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Christopher Loh has extensive experience counseling clients and litigating matters involving biotechnology and life sciences, including in the areas of antibody biosimilars, targeted cancer therapies, diabetes treatments and siRNA technologies. Christopher has a B.S. in Molecular Biochemistry and Biophysics and in Economics from Yale University.


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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