New Biologics Total Seven In 2007, But Only Four Will See Market
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA only approved one biologic with mass-market potential in 2007, a seasonal flu vaccine. Nearly half of the new biologics approved - three of seven - will not be available commercially. Another three are for orphan indications
You may also be interested in...
CBER New Biologic Tally Healthy In 2013, But For Innovation Look To 2014
Coagulation factors dominated the biologics center’s approvals in 2013, a solid year with eight novel BLAs cleared. Innovation level of 2013 CBER approvals was unremarkable, but first quarter of 2014 holds potential for advances in hemophilia and allergy treatment.
CBER New Biologic Tally Healthy In 2013, But For Innovation Look To 2014
Coagulation factors dominated the biologics center’s approvals in 2013, a solid year with eight novel BLAs cleared. Innovation level of 2013 CBER approvals was unremarkable, but first quarter of 2014 holds potential for advances in hemophilia and allergy treatment.
The Outliers: Ammonia N13 and Voluven
In 2007, both CDER and CBER included in their final count of novel approvals products that had been cleared under the 505(b)(2) pathway - which is an expedited type of application that relies on sharing data with similar products that are on the market (and thus making products approved as 505(b)(2) by definition not unique).