US Herceptin biosimilar one step closer as FDA accepts Mylan BLA

11-Jan-2017 - Last updated on 11-Jan-2017 at 14:10 GMT

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The US FDA will decide whether to approve Biocon and Mylan’s version of the Roche breast cancer drug Herceptin by the beginning of September.

Indian drugmakers Biocon and Mylan, which are developing six biosimilar monoclonal antibodies for global markets, announced today their first US submission has been accepted for review by the US Food and Drug Administration (FDA).

The biologics license application (BLA) for the proposed biosimilar version of Roche/Genetech’s Herceptin (trastuzumab) was filed through the 351(k) pathway and the Agency has given the date of September 3, 2017 as its decision date as to whether or not it is to be approved.

MYL-1401O was submitted to the Agency in November, and if approved the two companies say it will be the first biosimilar to challenge Herceptin 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,” Mylan’s president Rajiv Malik said in a statement.

Biocon CEO Arun Chandavarkar added: “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 biosimilar trastuzumab is also under review by the European Medicines Agency (EMA).