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Results: 1-10 of 901

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA, European Union
  • August 2 2018

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S


FDA to Hold Public Hearing on Biosimilar Action Plan
  • Knobbe Martens
  • USA
  • July 31 2018

On July 18, 2018, the FDA released a Biosimilar Action Plan that is aimed at promoting competition and affordability across the market for


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


Biosimilars Action Plan Update
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • July 24 2018

As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018


The Latest: FTC to Look Closely at Competition between Biologics and Biosimilars and Patent Protection Strategies of Branded Manufacturers
  • McDermott Will & Emery
  • USA
  • July 24 2018

On July 18, 2018, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb delivered a speech at The Brookings Institution in Washington, DC


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’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • July 19 2018

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug


U.S. FDA Approves First Biosimilar to Neulasta
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • June 29 2018

Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta (pegfilgrastim). Neulasta was developed by Amgen and


FDA Withdraws Draft Guidance On Evaluation Of Analytical Similarity Between A Proposed Biosimilar Product And A Reference Product
  • Bergeson & Campbell PC
  • USA
  • June 29 2018

On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate


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