The European Medicines Agency (EMA) has accepted to review Mylan and Biocon ’s application for a biosimilar called Trastuzumab, used for certain breast and gastric cancers. Terming it as ‘milestone’ for the company, Biocon’s CMD Kiran Mazumdar Shaw says that marketing approval for the drug is likely to come in next 12-18 months. The addressable market for the drug is USD 7 billion, which opens up a huge opportunity for Biocon and Mylan both. Biocon, which had guided for 3-4 biosimilar approvals in FY17, has filed for an approval already and plans to file two more in second half of the current fiscal, Shaw says. The biggest ramp-up for the company currently is getting approvals from Europe markets. There is visible traction in emerging markets as well, she says adding that ex-US and Europe market look attractive for the company. Biocon’s insulin Glargine has recently received approvals from Japan and Mexico and is expected to get approvals in other markets as well.
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