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.
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The hotly contested case concerning biosimilar versions of Roche's Herceptin (trastuzumab) witnessed a seesaw shift after a division bench of the Delhi High Court held that the status prevailing prior to a stinging April 25 order against Biocon Ltd. and Mylan NV will continue to operate.
Swiss multinational Roche says that it "respects" the Indian regulator's recommendations to permit off label use of its anticancer, Avastin (bevacizumab), but has made it clear that it can't be held responsible for risks associated with prescriptions for indications other than the one the product is approved for.
Novartis and Intas Pharmaceuticals Ltd have reached an out-of-court settlement pertaining to their dispute concerning ranibizumab.