Drugmakers seeking FDA approval for biosimilars will pay application fees similar to charges for brand-name medicines.
The Food and Drug Administration plans to break down the cost to review so-called biosimilars into separate payments with more money charged up front during development, according to a proposal released today. The fees will be assessed annually and followed by application charges, establishment and product fees required for all drugs.
“Given that the approval pathway for biosimilar and interchangeable biological products is new, FDA services are most critical for continued and successful development of biosimilar and interchangeable biological products during the investigational stage prior to submission of a marketing application,” the agency said in its Federal Register notice.
The FDA’s proposal covers fiscal years 2013 to 2017, and comments will be accepted on the plan until June 9.
