Indian Avastin Versions Head For Debut; Watch Off-Label Space

Cut-price versions of Roche's anticancer, Avastin (bevacizumab), may well be on their way to the Indian market after a key local expert panel recently recommended the biosimilars for marketing. And "improvements" to facilitate off-label use of the product also appear to be on the agenda of some biosimilar players.

A subject expert committee (SEC), which advises the Indian regulator on trial-related permissions as part of a layered approval process, has recommended for marketing authorization bevacizumab versions of Intas Pharmaceuticals Ltd. and Hetero Drugs Ltd.

The Intas product has been cleared in metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology...

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