Mylan and Biocon submit FDA application for Trastuzumab biosimilar

Posted: 9 November 2016 | | No comments yet

Mylan and Biocon have submitted a biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, to the FDA through the 351(K) pathway…

Mylan and Biocon have submitted a biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the US Food and Drug Administration (FDA) through the 351(K) pathway.


This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and Biocon believe that this has the potential to be the first submission of a proposed biosimilar trastuzumab in the US.

The submitted BLA includes a comprehensive package of analytical similarity, nonclinical and clinical data. The clinical data consists of two pharmacokinetic studies and the HERITAGE confirmatory efficacy and safety trial.

Mylan President Rajiv Malik commented: “The FDA submission for biosimilar trastuzumab marks Mylan’s first FDA biosimilar submission from our portfolio of biosimilar products in development and our product has the opportunity to be the first biosimilar trastuzumab approved in the US.

This submission also is another demonstration of the strength of the Mylan/Biocon partnership and our shared commitment to increasing access to these critical medicines worldwide. Our trastuzumab biosimilar is already being sold in 11 developing markets, including India, and we look forward to bringing the product to market in the US and Europe upon approval.”

Dr Arun Chandavarkar, CEO & Joint MD, Biocon, commented: “Cancer patients in India and emerging markets have benefited with our trastuzumab and this advancement in the US will enable us to enhance access to this affordable therapy to larger patient pools.”

About Biocon and Mylan Partnership

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed for the global marketplace. Mylan has exclusive commercialisation rights for the proposed biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand and in the EU. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

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