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Sandoz drops rituximab after US seeks more data

Executive Summary

Sandoz will not pursue biosimilar rituximab in the US, the company has announced, following a complete response letter (CRL) from the US Food and Drug Administration (FDA) earlier this year asking for more information on the candidate. The CRL – issued in May (Generics bulletin, 11 May 2018, page 1) – came despite the firm’s biosimilar rituximab already being approved in markets such as the European Union (EU), Japan and Australia.

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