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
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