The Blockbuster Bubble: What is the Real Trend in R&D Output?
This article was originally published in RPM Report
The years 1996 and 1997 were terrific for the biopharmaceutical industry, with record numbers of new product approvals. It is now clear, though, that they were outliers from the historic rates of new product flow. That fact has important implications: the products approved in those years are the blockbusters industry is still living on, and they supported massive infrastructure that Big Pharma now needs to shed.
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New molecular entity approvals dipped in 2010 and Innovative Commercial Therapies dropped even more sharply. Add to that a significant drop in filings in 2010 and it is hard to be optimistic about a turnaround in approval numbers any time soon.
Its official: FDA's drug center has already approved more new molecules in 2008 than it did in 2007-despite missed user fee deadlines, a regulatory posture defined as "Safety First" and a general perception that it's never been harder to get drugs to market. Maybe there is an upside to the new regulatory system after all.
So far, the approval trends for new molecular entities and novel biologics in the first half of 2008 suggest that this year's final tally may look very similar to last year's record-low approval total