'Marketers are having a field day'

Doctors, drug companies, and government officials are growing increasingly concerned that the makers of the most advanced drug therapies are using scare tactics to ward off emerging generic versions of their products.

Doctors, drug companies, and government officials are growing increasingly concerned that the makers of the most advanced drug therapies are using scare tactics to ward off emerging generic versions of their products. FDA Commissioner Scott Gottlieb and others have warned that the companies that make costly name-brand biologic drugs are sowing doubt about the wisdom of switching to biosimilars—even though FDA has certified they are safe and effective. Biologics have led to breakthroughs against serious diseases, but they are hugely expensive. The campaign against those biosimilars could delay affordable access to a host of novel therapies, hurting patients and driving up health care costs. "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, Gottlieb said. The messages "can potentially undermine consumer confidence in biosimilars in ways that are untrue." He indicated 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.