Approval of new biopharmaceuticals 1999-2006: comparison of the US, EU and Japan situations.

Biopharmaceuticals, defined as either proteins derived from recombinant DNA technology (rDNAs) or therapeutic monoclonal antibodies (mAbs), have become the therapeutics of significance in the 21st century. This article identifies the new biopharmaceuticals approved in the three major pharmaceutical markets (US, EU and Japan) and analyzes the so-called "drug lag" in said regions. Between 1999 and 2006, a total of 65 new biopharmaceuticals were approved. Of this total, 59 (90.8%) were approved in the US, 52 (80.0%) in EU and 22 (33.8%) in Japan. The mean approval lag was 3.7 months in the US, 7.5 months in EU and 52.6 months in Japan. The US was ahead of the two other regional markets in approvals of biopharmaceuticals, while there was a significant drug lag in Japan. The authors also found that US companies were the licensors of 42 out of 65 new biopharmaceuticals, followed by European companies with 21 licensors and Japanese companies with only 2 licensors. These figures suggest that Japanese companies are still weak in biopharmaceuticals innovation and licensing, and this weakness appears to be a major contributing factor to the drug lag in the country.