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How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA, European Union
  • October 29 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


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 Final Guidance on “Labeling for Biosimilar Products”
  • Cozen O'Connor
  • USA
  • October 18 2018

The FDA’s final “Labeling for Biosimilar Products Guidance for Industry” (Final Guidelines) should be viewed as a clear effort to boost timely access


Global moves to reduce the future cost of publicly funded medicines
  • King & Wood Mallesons
  • USA, Australia, Global
  • October 5 2018

The most significant advances in medical treatments are being made with biological products that are significantly more expensive than traditional


FDA Estimates for Formal Meetings Regarding Development of Biosimilars Show Continued Growth of Biosimilars in the United States
  • Duane Morris LLP
  • USA
  • October 2 2018

FDA's upward projection is consistent with independent estimates of potential biosimilar cost savings in the United States. Among the key aspects in


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


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
  • 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