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Home Industry News Mylan reports positive study data for new biosimilar trastuzumab

Mylan reports positive study data for new biosimilar trastuzumab

7th June 2016

Mylan and partner Biocon have announced clinical trial data showing the efficacy of their new biosimilar version of the cancer drug trastuzumab.

Results from the phase III HERITAGE study have been presented at the 2016 American Society of Clinical Oncology annual meeting in Chicago, confirming the efficacy, safety and immunogenicity of the new biosimilar, dubbed MYL-1401O.

The new drug has shown a comparable performance to the original branded version of trastuzumab among patients with HER2-positive metastatic breast cancer, meaning MYL-1401O could represent an effective yet affordable new option.

Results from this study will be used to support regulatory filings of this new biosimilar product in developed markets.

Rajiv Malik, president of Mylan, said: "As one of the first companies in the industry to successfully complete a confirmatory efficacy and safety study comparing a proposed biosimilar to a branded cancer drug, this is a significant milestone for Mylan's biosimilar programme."

Trastuzumab is indicated for the treatment of HER2-positive metastatic breast cancer, as well as for the adjuvant treatment of HER2-overexpressing breast cancer and metastatic gastric cancer.ADNFCR-8000103-ID-801819870-ADNFCR

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