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Results:1-10 of 94

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FDA Withdraws Draft Guidance on Evaluating Analytical Similarity Following Industry Criticism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


FDA Approves Pfizer’s EPO Biosimilar
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • May 16 2018

Yesterday, Pfizer announced that FDA had approved Retacrit (epoetin alfa-epbx), a biosimilar of Amgen’s Epogen and Johnson & Johnson’s Procrit


Amgen v. Adello: A Blind Biosimilar Infringement Lawsuit
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 9 2018

Last month, Amgen sued Adello Biologics, a US-based biosimilar maker, for patent infringement under the Biologics Price Competition and Innovation Act


Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar Marketing Application
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 6 2018

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal