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
Sr. Regulatory Specialist, Biotech Center of Expertise
BASF, The Chemical Co.
San Diego, CA
Food Lawyer
Cargill
Wayzata, MN
Director of Clinical Research
Regenesis Biomedical, Inc.
Scottsdale, AZ
Actuary
Meridian Health Plan
Detroit, MI
Assistant Vice President - Dental Director
MetLife
Bridgewater, NJ