Biosimilar Podium Promotion: FDA Emphasizes Advantages Of Abbreviated Pathway

Biosimilar products are not intended to be stand-alone development programs, agency stresses, noting that early analytical data can allow for more targeted clinical trials later.

FDA has shifted to stressing the abbreviated part of the biosimilar development pathway, assuring sponsors that they can limit their required clinical demonstration with early analytical work.

Agency officials said characterization data will play a significant role, rather than clinical evidence, in part because the purpose of a biosimilar development program is to establish a product’s similarity...

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