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Republicans, Democrats, and Pharma Debate Trump Drug Pricing Proposal

USA - January 22 2019 Last October, the Trump Administration announced its plan to lower prescription drug prices by adopting foreign price controls on certain drugs...

Michael Fresco.

Amgen Brings Third BPCIA Lawsuit Against Apotex After Losing Two Others

USA - August 8 2018 Amgen has sued Apotex in connection with Apotex’s efforts to market biosimilar versions of Amgen’s cancer drugs Neupogen (filgrastim) and Neulasta...

Nathan Monroe-Yavneh.

FDA Issues Final Guidance on Biosimilar Labeling, Sticking with Generic Model

USA - July 30 2018 Earlier this month, FDA issued final guidance on the labeling of biosimilar products. The final guidance continues the approach adopted in FDA’s March...

Jacob F. Siegel.

FDA Announces Biosimilars Action Plan with Surprising Rhetoric

USA - July 23 2018 On July 18, FDA released its long-awaited Biosimilars Action Plan (“BAP”). In prepared remarks to the Brookings Institution the same day, FDA...

Michael Fresco.

Senator Hatch’s New Legislation Would Eliminate IPR Challenges by Generics and Biosimilar Makers

USA - June 18 2018 Generics and biosimilar makers have increasingly used inter partes reviews (“IPRs”), proceedings made possible by the America Invents Act, to...

Andrew D. Cohen.