Mylan N.V. and Biocon Ltd. said they submitted Mylan’s biologics license application for a proposed biosimilar Trastuzumab, to the U.S. Food and Drug Administration.
Biosimilar trastuzumab is a proposed biosimilar to branded Trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers.
HER2-positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.
Mylan and Biocon said that this has the potential to be the first submission of a proposed biosimilar trastuzumab in the U.S.
Mylan President Rajiv Malik said, “The FDA submission for biosimilar trastuzumab marks Mylan’s first FDA biosimilar submission from our broad portfolio of biosimilar products in development and our product has the opportunity to be the first biosimilar trastuzumab approved in the U.S.”
“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 U.S. and Europe upon approval.”
The submitted license application includes a 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.
Dr Arun Chandavarkar, CEO & Joint MD, Biocon, said, “Cancer patients in India and emerging markets have benefited with our trastuzumab and this advancement in the U.S. will enable us to enhance access to this affordable therapy to larger patient pools.”
Mylan and Biocon are partners on a portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace.
Mylan has commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.
Biocon has co-commercialization rights with Mylan for the product in the rest of the world.
Mylan is a global pharmaceutical company which offers a more than 2,700 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS worldwide depend.
It has markets in more than 165 countries and territories with 40,000 employees.
Biocon Limited is India’s largest and fully-integrated biopharmaceutical company.
Some of its key brands are INSUGEN (rh-insulin), BASALOG (Glargine), CANMAbTM (Trastuzumab), BIOMAb-EGFRTM (Nimotuzumab) and ALZUMAbTM (Itolizumab), an anti-CD6 monoclonal antibody.