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Results:1-10 of 109

The 2019 U.S. Federal Government Shutdown and its Potential Impact on Biologics
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • January 9 2019

On December 22, 2018, the United States federal government entered a partial shutdown, which now enters its 19th day. If the shutdown continues


FDA Withdraws Proposed Rule Abolishing Generic Preemption; Recognizes “Downsides” Of Expanded Tort Liability
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • December 17 2018

On December 13, 2018, the FDA withdrew a proposed rule that would have authorized manufacturers of generic drugs to use the Changes Being Effected


Bill Requiring Disclosure of Biosimilar Settlement Agreements to the FTC and DOJ Becomes Law
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • October 29 2018

Earlier this month, the President signed into law the Patient Right to Know Drug Prices Act (Public Law 115-263). The Act mainly focuses on


FDA Issues “PlayBook” for Medical Device Cybersecurity
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • October 4 2018

The Food and Drug Administration is stepping up its game with respect to the cybersecurity of medical devices. On Monday, the agency announced its


New Arguments in Momenta On Standing to Appeal IPR Loss Before Filing a Biosimilar Application
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • September 12 2018

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal


FDA Approves Pfizer’s Biosimilar of Neupogen as Amgen and Pfizer Litigate Patent Infringement
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • August 9 2018

On July 20, 2018, FDA approved Pfizer’s biosimilar of Amgen’s Neupogen (filgrastim). Pfizer’s product, Nivestym, is the second biosimilar of


FDA Issues Final Guidance on Biosimilar Labeling, Sticking with Generic Model
  • Patterson Belknap Webb & Tyler LLP
  • 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


FDA Announces Biosimilars Action Plan with Surprising Rhetoric
  • Patterson Belknap Webb & Tyler LLP
  • 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


FDA Withdraws Draft Guidance on Evaluating Analytical Similarity Following Industry Criticism
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • June 27 2018

Analytical studies to demonstrate that a biosimilar is highly similar to its reference product are central to the biosimilar development and approval


Senator Hatch’s New Legislation Would Eliminate IPR Challenges by Generics and Biosimilar Makers
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • June 18 2018

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