Trade Association Comments from FDA Biosimilars Hearing

Here's a post from PharmaTech Talk blog that captures selected comments from the 3 major pharmaceutical trade associations - Pharmaceutical Reseach and Manufacturers of America (PhRMA), Biotechnology Industry Organization (BIO), and Generic Pharmaceutical Association (GPhA).

PharmTech Talk » Trade Association Roundup from Biosimilars Hearing.

As one might surmise, there are differing points of view on how easy the FDA should make follow on biologic approval, how products should be named/labelled, on interchangeability, and data exclusivity.  For your reading pleasure.

Also, here is the PhRMA press release  and GPhA press release from their websites.

 

Posted by Bruce Lehr November 4th 2010.