Former FDA official: Biosimilar pathway won't bring a revolution

03/27/2013 | Forbes

The FDA's abbreviated pathway for most biosimilars will not have a considerable effect on costs nor cause a major change in the drug development landscape, writes Henry I. Miller, a former FDA biotechnology official. The high costs of planning and conducting clinical trials and analyzing the results will inhibit the rush to produce biosimilars. Each biosimilar has to be considered effectively as a novel treatment, making for a much more expensive process than the development of small-molecule generics.

View Full Article in:

Forbes

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Counsel – Regulatory Affairs
RAI Services Company
Winston Salem, NC
Director of Program Development
AdvaMed
Washington DC, DC
Director of System QA
LifeWatch Services, Inc.
Rosemont, IL
Director of Business Development and Membership
AdvaMed
Washington DC, DC
Director, Corporate Counsel
Regeneron
Tarrytown, NY