The Orange Book blog ran a nice summary of this, but to watch a videotape of yesterday's Enzi-Kennedy Senate Committee hearing, click here. (It starts at 17:25...before that, you will hear clanging coffee cups and rustling papers). Among the experts testifying was Novartis/Sandoz VP, Dr. Ajaz Hussain, formerly deputy director of the Office of Pharmaceutical Sciences at CDER (and known in very different circles as the "father of process analytical technologies (PAT)")
Amazing that these videos and transcripts are available so soon. (Video quality is another thing, though....just keep the screen size small to avoid the funhouse mirror effect)
Among the key issues: would full clinical trials be required, or would more limited studies (e.g. pharmacokinetics) suffice?
Read Ajaz Hussain's testimony on Followon Biologics, J&Js Siegel 's J&Js Siegel testimony at biosimilars committee meeting and the EC's Dr. Nicholas Rossignols testimony here.
The video's a bit like Grade B C-Span, but the personalities of the senators and speakers still come through. Senator Enzi, for instance, uses endearingly homespun similes to contrast generic small molecule drugs with biogenerics, with a regular generic being like a "starter house" and a biogeneric, like a "skyscraper."
-AMS
