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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


Global Approvals for Insulin Glargine Promise a More Affordable, Long-Acting Treatment for Diabetes
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • April 3 2018

Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee, received marketing approval from


Washington Healthcare Update - Feb 19, 2018
  • McGuireWoods LLP
  • USA
  • February 19 2018

While the President’s budget is not likely to be acted upon by Congress, it does signal what the administration’s priorities areas well as what


District Judge Dismisses Amgen’s Declaratory Judgment Suit Over Avastin Biosimilar
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • February 2 2018

On February 2, 2018, U.S. District Judge George H. Wu granted Genentech’s motion to dismiss a complaint brought by Amgen in the Central District of


Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • January 24 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


Sandoz v Amgen: An update
  • Bristows LLP
  • USA
  • January 9 2018

In our most recent publication, the Bristows' Biotech Review (Page 3), we reported on the US Supreme Court decision which, at the time, was the latest


2017 Biosimilar Approvals in Europe
  • Patterson Belknap Webb & Tyler LLP
  • European Union
  • December 21 2017

The European biosimilar market has expanded at record pace in 2017. The EMA approved marketing of sixteen biosimilar products referencing seven


US Biosimilar Approvals Soar in 2017
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • December 18 2017

Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved


Federal Biosimilars Act Preempts State Law
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • December 14 2017

On December 14, 2017, the Federal Circuit issued an opinion in Amgen v. Sandoz, holding that the Biologics Price Competition and Innovation Act of