Aurobindo Pharma has announced that its subsidiary CuraTeQ Biologics (CuraTeQ) has submitted Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for BP14, an oncology biosimilar product.

According to Dr Satakarni Makkapati, CEO, CuraTeQ, "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 our second product, another oncology biosimilar in the regulated markets, in this calendar year.’’

He further added, “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 the oncology segment is a testament to our commitment in expanding biosimilars treatment options for patients suffering from debilitating diseases.”

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 calibre 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.’’