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On April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. on two questions regarding the Biologics Price Competition and Innovation Act (“BPCIA”): (1) whether a biosimilar applicant’s 180 days’ notice of commercial marketing is properly given only after its biosimilar product has been approved by the FDA, and (2) whether a biosimilar applicant is obligated to provide its abbreviated biologics license application (“aBLA”) and manufacturing information to the reference product sponsor within 20 days after the FDA accepts the aBLA for filing, thereby triggering early patent litigation.

 

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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.

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). 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 (www.fda.gov). 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 Fitzpatrick BiologicsHQ database.

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