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Amgen handed CRL on trastuzumab in US

Executive Summary

Amgen received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its Kanjinti (trastuzumab) biosimilar following a recent target action date, the company has disclosed to Generics bulletin. Responding to enquiries, an Amgen spokesperson said the response letter – informing the firm that its biologics license application (BLA) is not yet ready for approval – was not expected to “impact our US launch plan”. The US-based firm, however, did not expand on its launch strategy.


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