FDA’s Plan for Biosimilars: Science to Trump Dissonance
This article was originally published in The Gold Sheet
FDA aims to cut through dissonance over biosimilars by focusing on the analytical science.
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Agency officials are willing to meet with sponsors during their development programs to look at data and provide advice in part to ensure they remain on track, but also to promote a high first-cycle approval rate.
In comments on FDA’s three biosimilar draft guidances, PhRMA and BIO seek a more limited role in biosimilar approval decisions for clinical data involving foreign reference products than does GPhA, but all the trade associations believe that the foreign product needs to be made by the same company in the same facility as the U.S.-licensed reference product.
The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.