Biosimilar makers to pay user fees 'comparable' to innovators under US FDA proposal
This article was originally published in Scrip
The first five years of user fees for biosimilars and interchangeable biological product applications, or 351(k)s, are expected to be comparable to those that innovator manufacturers currently pay, the US FDA revealed on 9 May in laying out its proposed principles, structure and performance goals for a biosimilar user fee programme. But unlike innovators, biosimilar makers will be required to pay a significant amount of their fees at the investigational new drug application (IND) mark rather than the 351(k) application filing, the agency said.
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