FDA chief Scott Gottlieb wonders if the makers of biologics are sowing misinformation about biosimilars and says his agency may look into the matter.Gottlieb rattled the saber a bit, noting that the FDA could send warning letters to the drug companies involved, the Washington Post reports. Biolsimilars are much cheaper versions of the miracle drugs, biologics, that have been rolled into the battles against cancer, arthritis and other diseases. The makers of these drugs want to protect their profits but might be going overboard, says Gottlieb.
“I am worried that there are either deliberate or unintentional efforts by branded companies to create confusion,”Gottlieb tells the Post, though he declined to name specific companies or lobbying associations that may be spreading such misinformation. That misinformation includes suggestions that biosimilars may not be safe or effective.
Biologics fueled about 70% of the growth in drug costs between 2010 and 2015.
“At stake are savings to the U.S. health-care system that have been estimated at $54 billion to more than $200 billion over 10 years,” the Post reports.