On June 12, 2017 the Supreme Court issued a unanimous opinion in Amgen v. Sandoz, penned by Justice Clarence Thomas. The Court addressed two questions, stemming from the Federal Circuit’s 2015 decision in the case, on which certiorari had been granted: 1) whether a biosimilar applicant may be compelled under either federal or state law to provide the reference product sponsor with its biosimilar application (aBLA) and manufacturing information; and 2) whether a biosimilar applicant must provide 180 days’ notice of commercial marketing of its biosimilar product only after the product has been licensed by the FDA.

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Brendan O’Malley has extensive litigation and client counseling experience in technology areas including therapeutic monoclonal antibodies and antibody expression systems, transgenic mice, non-insulin peptide treatments for diabetes, and DNA sequencing. Brendan’s Ph.D. research at Tufts University School of Medicine focused on protein-protein interactions in hepatitis B and hepatitis D virion assembly.


    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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