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FDA Publishes "Purple Book" for Biosimilars

FDA Publishes "Purple Book" to Catalog Biologics, Interchangeable and Biosimilar Products - The US Food and Drug Administration (“FDA”) recently published its first “Lists of Licensed Biological Products with Reference...more

Northern District of California Interprets the Biosimilars Act and Limits Declaratory Relief for Biosimilar Manufacturer: What You...

In the first instance of a district court interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (“Biosimilars Act”), Judge Maxine E. Chesney (N.D. Cal.) dismissed a declaratory...more

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