Omalizumab Biologic is Changing the Face of Asthma Therapeutics

The Center for Biosimilars Staff
March 20, 2017
Several studies on omalizumab (Xolair), currently manufactured by Novartis through a partnership agreement with Genentech, recently presented at the 2017 Annual American Academy of Allergy, Asthma, and Immunology (AAAAI) meeting in Atlanta, Georgia, demonstrated why biologic therapies are considered by many to be the “future” of care.

Omalizumab, an injectable medicine for patients 12 years and older for treating severe-to-persistent allergic asthma not controlled by inhaled corticosteroids (ICS), was approved by the FDA in 2003 only for asthma. The indication was modified several times over the next decade, and included a warning of “slightly higher risk of heart- and brain-adverse events,” which was added in September 2014. While the warnings may have changed, the uses for this flexible biologic drug have clearly only begun to be discovered.

“Despite the availability of omalizumab since 2003, utilization trends have not been previously described,” observed 1 research team, headed by Matthew Rank, MD, a physician at the Mayo Clinic in Scottsdale, Arizona. The team identified 8545 patients who used omalizumab between 2003 and 2015. They excluded certain conditions in order to prevent “censoring based on insurance coverage,” and noted that individuals starting on the biologic peaked in 2005 at 9.56 new users per 100,000 insured people and declined to 5.22/100,000 in 2012. In 2015, that number had climbed back up to 12.13/100,000, although 59% of those users stopped using the drug after less than a year.

The increased usage and relatively short duration of use could be due, in part, to aggressive marketing on the part of Genentech, which forecasters predicted at the end of Q1 2016 would own about 40% of 2016’s “top 10 new drugs in peak projected sales,” in large part due to its biologic and biosimilar research. Back in the 1990s, Genentech “officially committed to oncology” in the words of then-CEO Arthur D. Levinson, PhD, and that decision led the company toward biopharmaceutical research that, including breakthrough treatments for multiple sclerosis and, eventually, to omalizumab, which was a blockbuster drug in 2014. Genentech and Novartis ultimately endured a nasty scandal when whistleblowers accused them of marketing omalizumab directly to healthcare providers for wide-ranging uses instead of the narrow window of use prescribed by the FDA. The fact remains that omalizumab usage spiked and has remained high since.


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