Actions by branded companies to undermine proven safe, effective biosimilars hurt patients. U.S. Food & Drug Administration Commissioner Scott Gottlieb shares his concerns in the Washington Post:
“I am worried that there are either deliberate or unintentional efforts by branded companies to create confusion” about the safety and effectiveness of unbranded biologic drugs, FDA Commissioner Scott Gottlieb said in an interview with The Washington Post. The messages “can potentially undermine consumer confidence in biosimilars in ways that are untrue.’’
Gottlieb did not name specific companies or groups. But an alliance of makers of the highly profitable advanced drug therapies issued some of the most glaring warnings about government-approved copies of their products: They could “put you in the emergency room.’’ They may carry “additional risks.’’ The “potential problems involve efficacy, safety.’’
Gottlieb indicated the FDA may take action if it determines a company is deliberately misleading the public about the safety of biologic copies, by issuing warning letters to the drugmakers involved.
Such messages about unbranded biologics “raise public health concerns,’’ he said. “They could negatively impact a patient’s judgment about an otherwise safe and effective product.’’
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.”