Research published in the Journal of the American Medical Association (JAMA) this month indicates that regulatory actions related to safety concerns have been issued for 23.6% of the biological medicinal products approved for sale in the US and EU between January 1995 and June 2008. Of the 174 biologicals approved for sale in the regions during that period (excluding vaccines, allergenic products, products for further manufacture and transfusion products), 41 of them received 82 regulatory actions related to safety, including 19 that received “block box” warnings. “System organ classes of general disorders and administration site conditions,” which are related to infusion reactions after injection or intravenous administration of a drug, accounted for 27% of the regulatory actions that were safety related. Infections and infestations accounted for 22% of the safety-related regulatory actions, immune system disorders represented 15.9% and neoplasms represented 12.2%. The biologics had a 14% probability of requiring a safety-related regulatory action within three years of their approval and a 29% probability within 10 years of their approval.

Source: JAMA