Initial Biotechnology Drug Copies May Get Brand-Name Fees
Drugmakers seeking U.S. approval for the first lower-cost copies of biologic medicines made from living cells should initially pay application fees similar to charges for brand-name medicines, regulators said.
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.
Generic-drug companies led by Teva Pharmaceutical Industries Ltd. (TEVA) and Novartis AG (NOVN)’s Sandoz division have urged the FDA to create a pathway to start reviewing biosimilars as required by last year’s health-care law. Access to lower-cost versions of biologic medicines for cancer, arthritis and rare genetic diseases would save $25 billion in a decade, the Congressional Budget Office estimates.
“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 European Union approved its first biosimilar in 2006. The FDA’s proposal covers fiscal years 2013 to 2017, and comments will be accepted on the plan until June 9.
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.
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