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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

Litigation vs. Licensing: Manufacturers of the Two Most Recently Approved Biosimilars Take Different Approaches to Reference Drug Patents
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • December 5 2017

The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb), which is

Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • November 16 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

CMS Revises Medicare Part B Biosimilar Coding and Payment Policies
  • Covington & Burling LLP
  • USA
  • November 8 2017

On November 1 and 2, 2017, the Centers for Medicare & Medicaid Services ("CMS") released two final rules addressing changes to Medicare Part B

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

FDA publishes draft guidance on statistical approaches to assessing analytical similarity of biosimilars
  • Loeb & Loeb LLP
  • USA
  • October 30 2017

The FDA issued a draft guidance document to assist with the marketing application submission for biosimilar products. As part of the application

Lawsuits Filed on the Same Day Regarding Amgen’s Avastin Biosimilar
  • Morgan Lewis & Bockius LLP
  • USA
  • October 26 2017

The cases show thateven given a recent US Supreme Court interpretation of the statuteuncertainty still exists about complying with the “patent