Biopharmaceutical approval times have dropped since the 80s

May 1, 2003

Pharmaceutical Representative

Biopharmaceutical products are taking less time to win Food and Drug Administration approval, but are taking longer to complete required pre-market studies.

Biopharmaceutical products are taking less time to win Food and Drug Administration approval, but are taking longer to complete required pre-market studies, according to analysis by the Boston-based Tufts Center for the Study of Drug Development.

According to the center, the mean approval time for new biopharmaceuticals has dropped by 21% - from 24.9 months for drugs approved from 1982 through 1989, to 19.7 months for 2000 through 2002.

During the same time, however, average clinical phase times for new biopharmaceuticals increased by 137% - from 31.2 months to 74.0 months.

"The net result is that the average combined clinical and approval time for biopharmaceutical products that received FDA approval in 2000 through 2002 was three years longer than it was in the 1980s," said Tufts Center Director Kenneth I. Kaitin.

On average, combined clinical and approval time for recently approved new biopharmaceuticals was 7.8 years, compared with 4.7 in the 1980s.

More complex and challenging

According to Kaitin, lengthening development times for biopharmaceutical products are due in part to the fact that development programs have become more complicated and challenging: "Two decades ago, the biotechnology industry focused on the development of products thought most likely to succeed."

According to lead investigator Janice M. Reichert, more complex and innovative substances are being developed today.

"The majority of biopharmaceuticals approved during the 1980s were biological proteins with well-understood functions ... or recombinant versions, such as insulin and human growth hormone," she said.

Added Kaitin, "Now the major challenge for the industry is to stop or, better yet, reverse the relentless trend toward longer clinical phase times." PR

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