Try our Advanced Search for more refined results

Expert Analysis

FDA's Biosimilar Rules Will Provide Testing Clarity

Law360, New York ( May 27, 2014, 3:43 PM EDT) -- The U.S. Food and Drug Administration's biosimilars guidances provide some rules of the road for successfully navigating the highway to approval of a biosimilars application under Section 351. The FDA's newest draft guidance on demonstrating biosimilarity reiterates aspects of the agency's past guidance on the subject, but it also offers a bit more insight on its current thinking regarding the stepwise clinical testing approach that it expects to see from applicants. Early and frequent discussions with the FDA regarding planned clinical studies remain key in order to best position an application for approval....

Law360 is on it, so you are, too.

A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.


A Law360 subscription includes features such as

  • Daily newsletters
  • Expert analysis
  • Mobile app
  • Advanced search
  • Judge information
  • Real-time alerts
  • 450K+ searchable archived articles

And more!

Experience Law360 today with a free 7-day trial.

Start Free Trial

Already a subscriber? Click here to login

Related Sections

Law Firms

Government Agencies

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!