The average time from investigational new drug (IND) filing to market was 6.7 years for 11 monoclonal antibodies (mABs) approved between 1994 and 2003 but shot up to 8.3 years for 12 mAbs approved between 2004 and March 9, 2011
Importantly, approved mAbs have proven their value to patients, physicians and third party payors despite the fact that a majority of these drugs (69% of currently marketed compounds) carry the FDA’s most stringent safety caution, a so-called “black box” warning, on their label. In fact, two FDA-approved mAbs were withdrawn from market post-licensure due to safety concerns.
The report also presents an in-depth examination of post-approval strategies that have broadened the patient populations and laid the foundation for blockbuster products, such as Centocor Ortho Biotech’s Remicade, which generated $7.1 billion in 2009 sales.Methodical label expansion, including judicious selection of an initial “landing indication” for the first approval sought, has been a hallmark of the most versatile and highest selling mAbs. For example, Remicade, Abbott’s Humira (originating from a collaboration between biotech company Cambridge Antibody Technology and Knoll), Genentech’s Avastin and Biogen Idec’s Rituxan represent four mAbs that are now approved in a total of 19 distinct indications and, collectively, these molecules generated more than $24 billion in 2009 sales.