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FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

USA - August 9 2018 On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to...

David M. Fox, George A. O'Brien.

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

USA - August 21 2017 On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support...

Bert Lao, Heidi Gertner, Komal A. Karnik, David Horowitz, Katelyn (Katie) Ruiz Medwid, Robert Church, Mike Druckman, George A. O'Brien, James S. Allred.

Supreme Court Issues Landmark Biosimilar Ruling

USA - June 13 2017 On June 12, 2017, the Supreme Court issued a unanimous ruling in Sandoz Inc. v. Amgen Inc. The case interprets two provisions of the Biologics Price...

David M. Fox, Philip Katz, James S. Allred.

Guide to Recent Biosimilar Activity by FDA and in the Supreme Court

USA - March 16 2017 The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final...

Marie A. Vodicka, James S. Allred.

The New Hatch-Waxman Regulations: A First Look

USA - November 1 2016 On October 6, 2016, FDA published a final rule implementing portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization...

Komal A. Karnik, Robert Church, David M. Fox, Philip Katz.