The period of marketing exclusivity enjoyed by a first-in-class drug in the US has fallen dramatically. A report released by the Tufts Center for the Study of Drug Development (TCSDD) shows, among other things, the time between FDA approval of a first-in-class drug and a second drug dropped from 10.2 years in the 1970s to 2.5 years in 2000–2003. The study also shows that 87% of follow-ons in the 1990s were already in clinical trials by the time the breakthrough drug was cleared, and that secondary products were often approved with a priority rating. This all points to a shorter period of market dominance by the pioneering drug. First-to-market means less and less these days, says TCSDD director Kenneth Kaitin, who adds that “if you've got a superior product, it doesn't make any difference whether you're first or eighth.” For firms looking to enter a market with a second-in-line product, that means evaluating the product for safety and efficacy and superiority before forging ahead. Daniel Ruppar, industry manager for pharmaceuticals and biotechnology in North America with Frost & Sullivan, of Mountain View, California, says that it's not necessarily preferable to have a second-in-class drug now, but admits that “the second drug can gain key learnings from the first,” and “what really matters is which is the better drug.”
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Carlson, B. First-to-market loses grip. Nat Biotechnol 27, 964 (2009). https://doi.org/10.1038/nbt1109-964b
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DOI: https://doi.org/10.1038/nbt1109-964b