Stakeholders Seek More Support for Biosimilars

FDA Commissioner Scott Gottlieb repeated the agency’s commitment to biosimilars and stakeholders urged the agency to do more to improve market access during a public meeting Tuesday.

Gottlieb expressed dissatisfaction with the current state of biosimilar access, noting that not even half of the approved products have entered the market. He also reaffirmed the agency’s commitment to discouraging gaming of biosimilar competition within the industry.

The public meeting drew reps of leading drugmakers including Andrew Greenspan, vice president of medical affairs at Janssen, who called on the agency to consider requiring post-marketing studies for biosimilars, saying this would increase provider confidence and lead to greater acceptance of biologic therapies. Greenspan noted that recently approved infliximab biosimilars did not require post-marketing commitments.

The agency should consider working with biosimilar sponsors to establish post-marketing registries or other markets for long-term safety data for special populations, he said.