Analysis: Recall could make FDA more cautious about biosimilars

02/26/2013 | Forbes

The recall of Affymax's anemia drug Omontys could prompt more caution from the FDA as it develops a pathway for the approval of biosimilar drugs, former FDA official Dr. Scott Gottlieb writes. "The agency has years of experience with biological agents that simulate red blood cell production, and the inability to ferret out the risks with Omontys is likely to underscore how hard this science remains," he writes.

View Full Article in:

Forbes

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Market Intelligence Manager
Olympus Corporation of the Americas
Southborough, MA
Regulatory Counsel
Food and Drug Administration
Silver Spring, MD
Pharmacy Care Manager
National Association of Chain Drug Stores
Arlington, VA
Vice President, Commercial Markets
Meridian Health
Neptune, NJ
Health Plan CEO – Oregon
Trillium Community Health Plan
Eugene, OR