The European Medicines Agency (EMA) has accepted for review Mylan's marketing authorisation application (MAA) for a proposed biosimilar Trastuzumab, MYL-1401O, to treat certain human epidermal growth factor receptor 2 (HER2)-positive breast and gastric cancers.
Co-developed under the partnership between Mylan and India-based Biocon, Trastuzumab is indicated for the treatment of certain HER2-positive early stage and metastatic breast cancer, as well as HER2-positive metastatic gastric cancer.
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Mylan noted that nearly two million women are diagnosed with breast cancer every year, with HER2-positive breast cancer being an aggressive form of breast cancer.
The MAA has been submitted based on analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy / safety global clinical trials for Trastuzumab.
Additionally, the filing includes data from the Heritage study, a Phase III double-blind, randomised clinical trial that evaluated comparative efficacy and safety of the proposed biosimilar, MYL-1401O, versus branded trastuzumab.
Mylan president Rajiv Malik said: "The acceptance of our regulatory submission of our proposed biosimilar Trastuzumab in Europe is another example of the strong progress we continue to make across our broad biosimilars portfolio.
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By GlobalData“Following our successful commercialisation in India and emerging markets, we look forward to our pending launch in Europe.
“Europe represents a key market for more affordable versions of these important products, as governments across the region strive to reduce healthcare costs. We look forward to continuing to work to bring this product to patients upon approval."
In July this year, EMA accepted for review Mylan's MAA for the proposed biosimilar Pegfilgrastim.
