A US Food and Drug Administration panel unanimously recommended approval for Biocon's biosimilar breast cancer drug. The recommendation takes Biocon closer to getting the FDA's marketing approval for Trastuzumab, which has a multi-billiondollar market globally. Trastuzumab, developed originally by Roche, is one of the most commonly used drugs to treat HER2-positive breast cancer. The Swiss company's drug is sold under the brand Herceptin worldwide and Herclon in India. A biosimilar is a copy of a biologic drug.
Biocon has developed the biosimilar in collaboration with US drug maker Mylan. The US FDA's Oncology Drugs Advisory Committee voted 16-0 in favour of the eligible indications of the original product, the panel tweeted early Friday India time. The next step for the two companies is to get a final approval from the US FDA to commercially launch the product. Biocon hopes for this approval by September 3, chairperson Kiran MazumdarShaw said.
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