USFDA accepts Mylan's BLA for proposed biosimilar Trastuzumab

Biotechnology major Biocon and pharma firm Mylan today said that the US health regulator has accepted Mylan's biologics license 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 USFDA acceptance of our BLA for proposed biosimilar trastuzumab marks an important step toward increasing access to this treatment option for patients in the US."
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 US 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 US, 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 US 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 US 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.