In a new blog post, physician and Cato Senior Fellow,  Dr. Jeffrey A. Singer warns that the FDA’s burdensome biosimilar approval process is stifling competition and keeping drug prices high.

Singer points to costly user fees and excessive clinical requirements as key barriers, despite Congress’s intent to encourage biosimilar development.

“Congress created a pathway for biosimilars, but today that pathway is clogged,” he writes.

Singer calls on lawmakers to ease FDA-imposed hurdles and streamline approvals to allow more affordable alternatives into the market.

To speak with Dr. Singer on this subject, please reach out to esalamon@​cato.​org