After Lull In Biosimilar IP Litigation, 2021 Could Bring Influx

Law360 (January 7, 2021, 5:35 PM EST) -- A biosimilar is biological product that is highly similar to and has no clinically meaningful differences from an existing approved reference biological product.

Much like the Hatch-Waxman Act did for generic drugs decades ago, the Biologics Price Competition and Innovation Act, enacted in 2010 as part of the Affordable Care Act, established an abbreviated regulatory pathway and unique patent litigation framework for biosimilars in the U.S.

Through this pathway, the U.S. Food and Drug Administration approved the first biosimilar in 2015 and progressively approved more biosimilars each year. To date, the FDA has approved a total of 29 biosimilars, of which...

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