Healthcare and government officials are growing concerned that biologic makers are using scare tactics to prevent generic versions of their products from entering or succeeding in the market, according to The Washington Post.
Physicians, generic drug companies and the FDA Commissioner Scott Gottlieb, MD, said that companies that make costly biologic drugs, derived from living cells, are trying to plant seeds of doubt about the efficacy of cheaper, unbranded versions of their medications, called biosimilars.
Concern is arising that an industrywide misinformation marketing campaign about biosimilars will discourage acceptance of the generic, lower-cost versions, even though the FDA has certified them as safe and effective.
"I am worried that there are either deliberate or unintentional efforts by branded companies to create confusion" about the safety and effectiveness of biosimilars, Dr. Gottlieb told The Post. The messages "can potentially undermine consumer confidence in biosimilars in ways that are untrue."
According to Dr. Gottlieb, an alliance of biologic makers issued some glaring warnings against FDA-approved biosimilars, warning patients that they could "put you in the emergency room" carry "additional risks" or have issues with "efficacy and safety," The Post reports.
But these warnings are untrue, Dr. Gottlieb said.
Dr. Gottlieb said the FDA may take action if it determines a biologic maker is deliberately misleading the public about approved biosimilars.
Such messages "could negatively impact a patient’s judgment about an otherwise safe and effective product," Dr. Gottlieb said.
The report comes as policymakers try to get the rising costs of biologics under control. Biosimilars are expected to be priced about 10 percent to 51 percent lower than biologics.
Read the full report here.