Article preview from "The Pink Sheet"- January 30, 2012
With the same range of novel product submissions as in 2011, the year ahead could reach an equally healthy tally of new molecular and novel biological entity approvals. But a look at upcoming applications suggests that the makeup of those classes could be very different.
Article preview from "The Pink Sheet"- January 30, 2012
The biopharmaceutical industry starts 2012 with every chance of matching the high number of new molecular and novel biological entity approvals posted in 2011, but whereas 2011’s class of novel products was marked by a number of breakthroughs, the makeup of the class of 2012 is likely to be more conventional, slanted towards standard review products, small molecules and more experienced sponsors.
The number of NME and NBE submissions under review at FDA is likely to be in the same range in 2012 as in 2011, even though the makeup of the candidates is quite different. “The NME submission rate has not really changed,” Office of New Drugs Director John Jenkins told Elsevier Business Intelligence’s FDA/CMS Summit Dec. 8, 2011. As of Nov. 30, 2011, CDER had received 29 new molecular entity and new biologic entity submissions, which he characterized as “about on track for what we’ve seen in recent years.” The 29 submissions is actually an uptick from 22 in 2010, although off the high for the decade, 38 NME/NBE submissions to CDER in 2005, Jenkins’ data show.
The novel agents approved in 2011 are notable not only for the high number of approvals (30) but for a high number of approvals targeting significant unmet medical needs, making a giant leap forward in treatment and a large number of first-time or “emerging” sponsors.
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