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BsUFA III: Reauthorization Process Begins With US FDA Considering Staffing, Uptake Issues

 
• By Derrick Gingery

Biosimilar availability may not be in the its purview, but the FDA still is thinking about ways to help industry deal with the issue and support sector growth.

FDA entrance sign 2016
The virtual BsUFA III kick-off meeting is scheduled for 9 a.m. to 12:30 p.m. on 19 November.

As industry and the Food and Drug Administration prepare to begin discussions on regulatory structure that will guide the second decade of biosimilars in the US, agency officials appear willing to test the limits of FDA’s purview and push into product availability issues as part of an effort to encourage more sector growth.

Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB), said that “important factors affecting availability of biosimilars in the marketplace and on formularies” lie outside the agency’s traditional remit, but that the agency

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