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Biosimilar Sponsors Push US FDA To Speed Up Supplement Reviews

Executive Summary

Although the agency committed to six-month reviews of biosimilar and interchangeable supplemental applications, stakeholders say that time should, at minimum, be cut in half. Meanwhile, PhRMA's comments on a supplemental applications draft guidance urge the FDA to ensure interchangeability is demonstrated for all indications, even when some of those uses are ineligible for approval due to patent and exclusivity protection. 

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