FDA to review Biocon and Mylan’s biosimilar drug for breast cancer

The US Food and Drug Administration (FDA) has accepted Mylan’s biologics license application (BLA) for the biosimilar, MYL-1401O, for review through the 351 (k) pathway.

The expected FDA goal date set under the Biosimilar User Fee Act is 3 September 2017.

The proposed biosimilar version of trastuzumab is indicated to treat several breast and gastric cancers. It is one of the six biologic products co-developed by Mylan and Biocon for the worldwide marketplace.

Mylan has exclusive commercialization rights for MYL-1401O in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.

Biocon holds co-exclusive commercialization rights with Mylan for the product in the remaining parts of the world.

Mylan President Rajiv Malik said: "The FDA acceptance of its BLA marks an important step toward increasing access to this treatment option for patients in the US.

Malik said: “We believe that our comprehensive package of analytical similarity, non-clinical and clinical data submitted with the BLA will demonstrate similarity of the proposed biosimilar trastuzumab to the reference product.

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."

The European Medicines Agency is also reviewing Mylan and Biocon's proposed biosimilar trastuzumab.

Image: Biocon building. Photo: courtesy of Biocon.