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Dr Reddy’s Knocked Back On Rituximab In US

Biosimilar Rival To Rituxan Receives Complete Response Letter From FDA

 
• By Dave Wallace

Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to Rituxan.

Stop sign in front of US flag
Approval of Dr Reddy’s rituximab has been blocked in the US • Source: Shutterstock

Dr Reddy’s has disclosed that its US application for a biosimilar version of Rituxan (rituximab) has been knocked back by the US Food and Drug Administration, which has issued a complete response letter over the filing tied to a recent facility inspection as well as aspects of the firm’s biologics license application.

Early last year, Dr Reddy’s had indicated that it was ready to move ahead with rituximab filings in developed markets such as the US and Europe

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