New Report Shows Monoclonal Antibody Development Times Are Lengthening

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  In fact, two FDA-approved mAbs were withdrawn from market post-licensure due to safety concerns.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.