FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab

If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the US.

Mylan and Biocon have announced that FDA has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 3 September 2017.

Mylan President Rajiv Malik commented: "The FDA acceptance of our BLA for proposed biosimilar trastuzumab marks an important step toward increasing access to this treatment option for patients in the US. 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. We are committed to bringing this product to market and look forward to working with FDA over the next months. 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."

Dr Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: "We are delighted by the FDA's acceptance of the BLA for our proposed biosimilar trastuzumab. 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. 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."

Mylan and Biocon's proposed biosimilar trastuzumab is also under review by the European Medicines Agency (EMA).