How can biosimilar sponsors make the best use of the second Biosimilar User Fee Agreement (BsUFA II)?
FDA's Leah Christl, associate director for therapeutic biologics in the Center for Drug Evaluation and Research, was asked this question...
Best Of Biosimilar Agreement: FDA, Industry Tout Written Response, Pre-Submission Meeting
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FDA's Leah Christl and Amgen and Sandoz representatives discuss key achievements of BsUFA II at DIA meeting; Christl expects to see interchangeable biosimilars come to market within the next two years.
Learn what's happening at the US FDA. On the go.
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