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FDA pulls policy on biosimilar development after comment period

FDA draft guidance on statistical methods to evaluate similarity between brand-name drugs and biosimilar copies was withdrawn by the agency after it received comments. Pharmaceutical Scientist founder Sarfaraz Niazi submitted a citizen petition asking the agency to waive bridging studies for qualified non-US comparator drugs, encourage payers to cover biosimilars only for new patients and rethink analytical similarity testing protocols.

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