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White Paper | Biosimilars - 2019 Year in Review

January 31, 2020

White Paper | Biosimilars - 2019 Year in Review

January 31, 2020

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In many ways, 2019 was a notable year for biosimilars in the U.S.  FDA approved the 26th biosimilar product and the 13th biosimilar product was launched in the U.S. market.  These developments were accompanied by a flurry of activity at FDA, new proposed and enacted legislation, and new developments in court and in post-grant proceedings.  Below, we review the developments in the field in terms of biosimilar approvals and launches, FDA guidance on biosimilars, pending biosimilar legislation, litigation under the Biosimilars Price Competition and Innovation Act (BPCIA), litigation related to alleged anticompetitive behavior on the part of reference product sponsors, and biologic-related post-grant challenges.

Click to download the Fish & Richardson White Paper | Biosimilars – 2019 Year in Review today.

Authors: Jenny Shmuel, Ph.D., Tasha Francis, Ph.D., Philip Chen, and Felix Eyzaguirre


The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.

Related Tags

biosimilars
bpcia
biosimilar
biologics-price-competition-and-innovation-act-bpcia

Blog Authors

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Jenny Shmuel, Ph.D. | Principal

Jenny Shmuel, Ph.D., represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and cross-examined witnesses at trial. Over the last...

Boston attorney
Philip K. Chen | Associate

Philip Chen is an associate in the Boston office of Fish & Richardson P.C. His practice spans a wide range of technologies, including biologic pharmaceuticals, medical devices, navigation systems, and software. Philip has experience in various aspects of complex intellectual property litigation in both U.S. district courts and the U.S....

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