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BsUFA III Expands Biosimilar Supplement Review Goals To Speed Approvals

 
• By Derrick Gingery

Six supplement categories based on submission content will be created with review goals between three and 10 months.

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The FDA plans to hire an additional 15 employees to help implement the BsUFA III program changes.

The biosimilar supplement review system in the US will undergo a substantial expansion during the upcoming user fee cycle as part of an effort to streamline the process and create more certainty for sponsors.

Some supplements could receive as short as a three-month assessment under the new goals and categories in the BsUFA III commitment letter released on 21 September, which outlines program changes negotiated by industry and US Food and Drug Administration representatives

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