An employee in protective clothing arranges samples inside the research and development center at the Biocon Ltd. campus in Bengaluru, India (Photographer: Dhiraj Singh/Bloomberg)

U.S. FDA Accepts Mylan’s Application For Proposed Biosimilar Trastuzumab

Biotechnology major Biocon and pharma firm Mylan on Wednesday said that the U.S. health regulator has accepted Mylan's biologics licence application (BLA) for MYL- 1401O, a proposed biosimilar trastuzumab indicated for treatment of breast cancer. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the two companies said in a statement.

Commenting on the development, Mylan President Rajiv Malik said: "The U.S. FDA acceptance of our BLA for proposed biosimilar trastuzumab marks an important step toward increasing access to this treatment option for patients in the U.S." The company is committed to bringing this product to market and look forward to working with FDA over the next months, he added.

This is Mylan and Biocon's "first U.S. regulatory submission through the 351(k) pathway and reinforces the strength of our collaboration to increase access to a broad portfolio of high-quality, affordable biosimilars worldwide," Malik said.

Mylan has exclusive commercialisation 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, the statement said. Biocon has co-exclusive commercialisation rights with Mylan for the product in the rest of the world, it added.

"It is a major milestone for the Mylan and Biocon collaboration since it is the first U.S. regulatory submission through our joint global biosimilars program," Biocon CEO and Joint Managing Director Arun Chandavarkar said.

This development positions Biocon and Mylan among the first companies to be able to address the critical need of U.S. patients for a high-quality biosimilar to treat certain HER2- positive breast cancers, in the near future, he added.

Mylan and Biocon's proposed biosimilar trastuzumab is also under review by the European Medicines Agency (EMA), the statement said. The product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers, the companies said.

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products.