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. The next step for both the companies would be to get a final approval from the regulator to commercially launch the product.
A 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.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. 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. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.
“We are pleased with ODAC’s recommendation to support the approval of Mylan’s proposed biosimilar trastuzumab to increase affordability, competition and most importantly overall access and use. As one of the largest suppliers of cancer medicines by volume in the U.S., Mylan is committed to serving this important patient community. We look forward to working with FDA to further increase access to this important treatment option for the thousands of patients affected by HER2-positive breast cancer each year.” said Rajiv Malik, President Mylan.
Biocon MD Dr. Arun Chandavarkar said the company looks forward to seek a final approval from the FDA in order to expand access to a high-quality, affordable option for treating HER2-positive breast cancers.
Mylan and Biocon's proposed biosimilar trastuzumab also is under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.