BsUFA Delays Biosimilar Guides, But FDA Says Interchangeability On Track

An FDA official told Inside Health Policy Thursday (Oct. 27) the agency still plans to unveil the draft interchangeability guidance for biosimilars in 2016, even though the agreement for second iteration of biosimilar user fees says the guide will be delayed until 2017. The BsUFA II agreement, expected to be sent to Congress by the end of the year, stretches out timelines for guidances on key issues, including interchangeability and naming, prompting outcry from generic drug industry, health care professionals…

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