USA - November 30 2020
FDA has published new draft guidance for industry titled "Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and…
Jordan Engelhardt.
USA - February 27 2020
Last week, the U.S. Food and Drug Administration (“FDA”) issued a final rule to amend its regulation that defines the term “biological product” in…
Jordan Engelhardt.
USA - September 6 2019
In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®)…
Andrew D. Cohen, Jordan Engelhardt.
USA - July 31 2019
Amgen Inc. v. Coherus Biosciences Inc., No. 2018-1993, Slip op. at 6 (Fed. Cir. July 29, 2019) stems from a Biologics Price Competition and Innovation…
Jordan Engelhardt.
USA - July 16 2019
In Enzo Life Sciences v. Roche Molecular Systems, No. 2017-2498, 2017-2499, 2017-2545, 2017-2546, Slip op. (Fed. Cir. July 5, 2019), the Federal…
Jordan Engelhardt.