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Biosimilar Guidance Comments Reveal Small Window Of Agreement On Foreign Data

 
• By Sue Sutter

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.

Use of foreign comparator data to demonstrate biosimilarity should only be allowed if the foreign product is made by the same company and/or in the same facility as the U.S.-licensed reference product, the three major pharmaceutical and biotechnology trade groups say in comments on FDA’s biosimilar draft guidances.

The source of foreign reference products seems to be a rare area of agreement among the innovator industry groups – the Pharmaceutical Research and Manufacturers of America and Biotechnology Industry...

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