Aurobindo Pharma arm submits first biosimilar filing with EMA

Hyderabad: Drugmaker, Aurobindo Pharma Limited, has recently announced that the company's subsidiary CuraTeQ Biologics Pvt Ltd. has submitted Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for BP14, an oncology biosimilar product.

"The submission of BP14 MAA with EMA is an important beginning in our business evolution and positions CuraTeQ well in our mission of providing access to high quality biosimilars for cancer patients. We remain on track for filing oursecond product, another oncology biosimilar in the regulated markets, in this calendar year.

Earlier, we completed a successful Phase 1 clinical trial of a monoclonal antibody biosimilar product used for the treatment of multiple types of cancers. Another biosimilar from our oncology portfolio, currently in Phase 3 clinical studies has reached the 50% patient recruitment milestone this month and we hope to complete the recruitment in the next two quarters. Our focus on executing parallel clinical studies for multiple biosimilars in oncology segment is a testament of our commitment in expanding biosimilars treatment options for patients suffering from debilitating diseases," said Dr. Satakarni Makkapati, CEO of CuraTeQ.

Mr. K. Nithyananda Reddy, Vice Chairman, Aurobindo said, "I am pleased to see that our commitment to biosimilars business, backed by world-class infrastructure and high caliber team is starting to see positive momentum with our first regulatory filing, with more products in licensure clinical trials. Through CuraTeQ, we aim to develop biosimilars for strengthening our focus in oncology and immunology segments. In a relatively short time span, the progression of our biosimilars pipeline is encouraging and we look forward to commercialize these products through our established commercial presence across the globe."

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