Biosimilars companies urge Gottlieb to influence administration

Speaking at an FDA public hearing, representatives of biosimilars manufacturers Tuesday called on FDA Commissioner Scott Gottlieb to lobby federal agencies and Congress to address commercial practices that are limiting uptake of biosimilars. They also praised FDA’s Biosimilars Action Plan, and called for the agency to follow through with proposals in the plan that are aimed at easing the use of non-U.S.-licensed reference products.

While biosimilars companies urged FDA to smooth the regulatory and commercial paths for their products, manufacturers of original biologics pressed the agency to preserve exclusivity for original biologics, and to lay down regulatory speed bumps that could deter physicians from switching patients from chronic therapies to biosimilars...