US FDA accepts Mylan’s BLA for proposed trastuzumab product


Biocon and Mylan have announced acceptance of the latter’s biologics licence application (BLA) by the US Food and Drug Administration (FDA) for MYL-1401O, a proposed biosimilar trastuzumab.

Mylan’s MYL-1401O is indicated to treat certain HER2-positive breast cancers.

HER2-positive metastatic breast cancer is an aggressive form of breast cancer that tests positive for the human epidermal growth factor receptor 2 (HER2) that promotes cancer cell growth.

Nearly two million women across the globe are diagnosed with breast cancer every year.

Mylan president Rajiv 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.

"The product has been co-developed by Mylan and Biocon for the global marketplace and is also under review by the European Medicines Agency (EMA)."

“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.”

Biocon CEO and joint managing director Dr Arun Chandavarkar added: “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.”

The product has been co-developed by Mylan and Biocon for the global marketplace and is also under review by the European Medicines Agency (EMA).

Mylan has exclusive commercialisation rights for this product in the US, Canada, Japan, Australia, New Zealand and the European Union and European Free Trade Association countries. Biocon has co-exclusive rights with Mylan in the remaining parts of the world.