Mylan N.V. and Biocon Ltd file BLA at FDA for MYL 1401O a proposed biosimilar trastuzumab.
Mylan N.V. and Biocon Ltd. announced submission of Mylan's biologics license application (BLA) for MYL 1401O, a proposed biosimilar trastuzumab, to the 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 U.S.
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. The results of the HERITAGE trial were presented at this year's American Society of Clinical Oncology (ASCO) Annual Meeting and the European Society for Medical Oncology (ESMO) Congress.
Comment: Herceptin patents are not expected to expire until 2019 in the US but have expired in July 2014 in the EU.
Comment: The HERITAGE study successfully met the predefined endpoints of response equivalency. The response rates at 24 weeks were 69.6% with MYL 1401O combined with taxane chemotherapy versus 64% with branded trastuzumab combined with the same chemotherapy agent.
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