The U.S. Food and Drug Administration recently approved a license application for Mylan Biotechnology, in collaboration with Biocon, for the use of biosimilar tratuzumab in the treatment of breast cancer.
“The FDA acceptance of our application marks an important step toward increasing access to this treatment option for patients in the U.S.,” Mylan President Rajiv Malik said. “We are committed to bringing this product to market and look forward to waking with the FDA over the next months.”
The proposed trastuzumab is one of six products co-developed by the two companies. While a joint effort, Mylan maintains commercial rights to the products in the U.S., Canada, Japan, Australia, New Zealand and in the European Union.
“We are delighted by the FDA’s acceptance,” Biocon CEO Dr. Arun Chandavarkar said. “It is a major milestone for the Myland and Biocon collaboration. This development positions Biocon and Mylan among the first companies to be able to address the critical need of U.S. patients.”
FDA approves application for new breast cancer treatment
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