Sandoz Egypt Partners Up To Launch Rituximab Biosimilar
Projected Savings For NHL Estimated At 40%
Sandoz’ operation in Egypt has banded together with the Egyptian Cancer Society to introduce the firm’s biosimilar to Roche’s Rituxan/MabThera, three years after Hikma in-licensed a rituximab biosimilar from Celltrion.
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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.
Hikma Pharmaceuticals has reached its third biosimilar licensing agreement with Celltrion, acquiring exclusive rights to distribute and sell the South Korean firm’s Truxima (rituximab) biosimilar in the Middle East and North Africa (MENA).