Kanjinti Clinical Development Timeline
Executive Summary
Chronicle of the development and review of Amgen’s biosimilar to Genentech’s Herceptin.
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Kanjinti’s Path To Market Complicated By GMP Issues, Reference Product Drift
US FDA licensure of Amgen’s biosimilar to Herceptin was delayed by a complete response letter citing product manufacturing facility deficiencies; review documents discuss how drift in Genentech's reference product impacted the biosimilar program's analytical and clinical data.
Kanjinti Reviewers
US FDA staff who participated in the review and approval of trastuzumab-anns, Amgen’s biosimilar to Herceptin.
Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations
US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.