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Expert Analysis

The US Biosimilars Patent Litigation Outlook For 2019

By Joshua Whitehill and Michael Cottler (January 18, 2019, 3:49 PM EST) -- In 2010, President Barack Obama signed the Biologics Price Competition and Innovation Act into law as part of the Affordable Care Act, establishing an abbreviated regulatory pathway for biosimilar approvals and a unique litigation framework for resolving biosimilar-related patent disputes. The first biosimilar in the U.S., Sandoz Inc.'s Zarxio (filgrastim-sndz), did not reach the market through this pathway until late 2015. Since then, each year has seen more U.S. Food and Drug Administration approvals than the year before. 2018 was no different, boasting a record seven biosimilar approvals, bringing the total number to 16....

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