FDA’s Gottlieb Hits Innovators, Insurers for Blocking Biosimilar Uptake

“Pernicious” rebating and contracting schemes and “Kabuki drug-pricing constructs” expose consumers to high out-of-pocket costs for biosimilars and actively discourage competition from these more affordable alternatives, says FDA commissioner Scott Gottlieb. As part of FDA initiatives to reward innovation and promote patient access to medicines, the agency is working hard to support the development of high quality biosimilars and interchangeable products, he explained at a policy conference sponsored by America’s Health Insurance Plans (AHIP) in Washington, D.C. March 7. But high rebates paid by brand manufacturers to health plans and pharmacy benefit managers (PBMs) make it hard for biosimilars to compete. And Gottlieb fees that this reduces incentives for a biosimilar maker to make the investment needed to develop lower cost biologics.