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.
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In ongoing patent litigation with Genentech, Amgen may need to reveal its counsel's advice on whether it should launch, while Genentech must produce its settlement agreements with Mylan, Celltrion, and Pfizer.
Amgen and Allergan’s launch of the first biosimilars to Roche/Genentech’s Avastin and Herceptin may not face the same commercial dynamics that have stymied biosimilars in other therapeutic areas, but uptake could depend upon oncologists’ comfort level in prescribing the follow-on agents.
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