U.S. Food and Drug Administration (FDA) officials are concerned that drug companies are spreading misinformation about biosimilar versions of their products, potentially undermining confidence in the safety and efficacy of these FDA-approved agents.
In an interview with The Washington Post, FDA Commissioner Scott Gottlieb, MD, said, “I am worried that there are either deliberate or unintentional efforts by branded companies to create confusion.’’
Unbranded versions of biologic drugs have been slow to develop in the U.S. – the European Medicines Agency has approved more than 40 biosimilars, while the FDA has approved just 16. Alarmist marketing that questions the safety and efficacy of biosimilars further shakes market confidence in this class of drugs, potentially undermining efforts to develop them. This also has become a legal issue: Pfizer filed a petition against Amgen, Genentech, and Janssen Biotech, claiming the companies have unfairly suggested that copycat drugs are inferior.
In The Washington Post, Scott Foraker, vice president of Amgen’s unbranded biologics business responded to the allegations: “There is an unanswered question when you switch from one biosimilar to another. That’s an unanswered question scientifically.”
Source: The Washington Post, January 9, 2019.