FDA Has Received 9 Biosimilar INDs

Posted by Jonathan Loeb on April 30, 2012

As of February 15, nine Investigational New Drug applications have been lodged with FDA for 351(k) biosimilars.  That’s according to Rachel Sherman, the CDER Associate Director for Medical Policy, who presented the “Biosimilar Guidance Webinar” on that day.  Sherman provided some further statistics:

  • There have been 35 Pre-IND meeting requests for proposed biosimilar products to 11 reference products
  • 21 Pre-IND sponsor meetings have been held to date

So it looks like a number of companies are testing the U.S. biosimilar waters.  Given the lingering uncertainty over the requirements for approval, and the amount of data that has already been collected for some biosimilar products that have been approved in Europe, it is hard to guess when FDA will receive its first application for approval under 351(k).

Period for comment on Draft Biosimilars Guidance closed

Posted by Jonathan Loeb on April 17, 2012

Genetic Engineering & Biotechnology News published an interesting article summarizing some of the points found in comments submitted to FDA in response to its publication of the three draft guidances on biosimilar applications.  All sorts of stakeholders from biological innovators (Genentech and Novo Nordisk) to patient groups to a biosimilar manufacturer (Biocon) leveled criticisms at the Guidances.  We’ll see whether FDA takes any to heart in its final Guidances.