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New Report Says Biosimilars Could Save $54 Billion in Biologics Spending
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • November 7 2017

According to a new report by RAND Corporation, biosimilars could save $54 billion in healthcare spending on biologics over the next ten years


A path forward: Corportate Integrity Agreement sheds light on manufacturer interactions with independent charitable foundations
  • Hogan Lovells
  • USA
  • October 2 2017

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into


At The Bench: 2017 Mid-Year Case Review
  • Harness, Dickey & Pierce, PLC
  • USA
  • September 7 2017

The Supreme Court held that all patent rights are exhausted upon the first sale of a Patented product, regardless of where the sale is made or whether


Biosimilars in the US: the next frontier for big pharma
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • August 17 2017

The market for biological drug products is forecast to reach a global value of $400bn per year by 2025. Major pharmaceutical companies are investing


Patent Term Extension Considerations for BioPharma Patents
  • Sterne Kessler Goldstein & Fox PLLC
  • USA
  • August 15 2017

Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the


Janssen Biologic Tremfya Secures FDA Approval Following Use of Priority Review Voucher
  • Knobbe Martens
  • USA
  • July 25 2017

On July 13, 2017, the U.S. Food and Drug Administration approved Tremfya (guselkumab), a biologic manufactured by Janssen Biotech, for the treatment


FDA Holds Public Meeting on Innovation in Drug Development and Accelerating Access to Generic Medicines
  • Arent Fox LLP
  • USA
  • July 20 2017

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and Accelerating the access


Sandoz v. Amgen - Biosimilars at the U.S. Supreme Court
  • K&L Gates
  • USA
  • July 6 2017

The U.S. Supreme Court unanimously decided Sandoz Inc., v. Amgen Inc., on Monday June 12, 2017, construing the Biologics Price Competition and


Biosimilar Notice May Be Given Prior to FDA Approval
  • McDermott Will & Emery
  • USA
  • June 26 2017

In a unanimous decision, the Supreme Court of the United States explained that under the Biologics Price Competition and Innovation Act of 2009


Supreme Court Affords Greater Leeway to Biosimilars in the 'Patent Dance'
  • Pepper Hamilton LLP
  • USA
  • June 22 2017

In a recent ruling, the U.S. Supreme Court clarified what happens when biosimilar applicants do not follow the regulatory framework for disputes with