Published in:
01-10-2007 | Abstracts
Poster Presentations
Authors:
O. Lefebvre, S. Mayall, K. Seamon, L. Mclean, A. Banerjee
Published in:
Drug Safety
|
Issue 10/2007
Login to get access
Excerpt
Background: Following the successful experience of chemical generics and pushed by economic arguments for wider patient access to biological drugs, biosimilars are now coming onto the scene, with EMEA regulations currently taking shape and two initial hGH products approved in mid-2006. Despite significant enthusiasm and expectations, the question still remains to what extent they are clinically and commercially viable because of potential safety, manufacturing, regulatory and commercial risks. …