1. Generics Bulletin

Sandoz drops rituximab after US seeks more data

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.

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.

“We appreciate the important conversations with the FDA, which have provided specific requirements for our potential US biosimilar rituximab,” said Sandoz’ global head of biopharmaceuticals, Stefan Hendriks, “but believe the patient and marketplace needs in the US will be satisfied before we can generate the data required

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