MUMBAI: The US Food and Drug Administration on Friday approved Biocon and US drug maker Mylan's proposed biosimilar breast cancer drug Trastuzumab, a move that opens doors for Bangalore based Biocon in the big league of US cancer drug market The USFDA 's Oncology Drugs Advisory Committee voted 16-0 in support of the eligible indications of the original product. biosimilar drug is a identical copy of a biologic innovator drug. Trastuzumab is an original drug of Swiss drug maker Roche which is sold under brand name of Herceptin, it is one of the most commonly used drug to treat HER2-positive breast cancer. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.

Source: Economic Times July 14, 2017 03:00 UTC