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Medicines for Europe Issues 2017 Biosimilar Market Review
  • Pearce IP
  • European Union
  • September 13 2017

Eleven years after the launch of the first biosimilar product in EU, we are now in a position to calibrate our biosimilar market expectations with


Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
  • Rothwell, Figg, Ernst & Manbeck, PC
  • European Union, USA
  • September 6 2017

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


Case Note: Humiracase confirms no AU PTE for swiss style claims
  • Pearce IP
  • Australia
  • September 4 2017

In a case relating to patents for global blockbuster biologic Humira (Adalimumab), the Full Federal Court has drawn a bright line around the


The legal and regulatory challenges of getting a biosimilar product to market
  • CMS Cameron McKenna Nabarro Olswang LLP
  • European Union, USA
  • August 30 2017

The global biosimilars market is expected to reach $10.9 billion by 2021, according to the Biosimilars Global Forecast


Patented Medicine Prices Review Board releases July 2017 NEWSletter
  • Smart & Biggar/Fetherstonhaugh
  • Canada
  • August 23 2017

The Patented Medicine Prices Review Board released the July 2017 issue of its NEWSletter


CADTH issues Common Drug Review Update Newsletter
  • Smart & Biggar/Fetherstonhaugh
  • Canada
  • August 23 2017

The Canadian Agency for Drugs and Technologies in Health (CADTH) issued a Common Drug Review (CDR) Update on August 1, which includes the following


Amgen v Hospira: BPCIA dance lessons in the Federal Circuit
  • Pearce IP
  • USA
  • August 22 2017

Just over a week ago, the US Federal Circuit provided BPCIA “dance lessons” for reference product sponsors and biosimilar applicants, as it handed


Federal Circuit Provides More Guidance On Biosimilar Patent Litigation
  • Foley & Lardner LLP
  • USA
  • August 22 2017

In Amgen Inc. v. Hospira, Inc., the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that


Skipping the patent dance: U.S. Supreme Court in Amgen v sandoz makes it more difficult for patent owners to delay marketing of biosimilars
  • Ladas & Parry LLP
  • USA
  • August 18 2017

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the


The Impact of Biosimilars on Global Pharmaceutical Markets
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • August 17 2017

Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. AbbVie’s Humira