Aurobindo Pharma Limited — Updates, 31-01-2025: Press Release

CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has received a positive opinion from the CHMP of the EMA for Dyrupeg™ (BP14), a pegylated filgrastim biosimilar, paving the way for potential marketing authorization. The approval decision from the European Commission is anticipated in April 2025. Dyrupeg™ is designed to reduce the duration and incidence of neutropenia in patients undergoing chemotherapy for malignancies, excluding chronic myeloid leukemia and myelodysplastic syndromes.

This development follows a successful GMP compliance certification received from EMA in November and previous marketing approvals for other biosimilars. Aurobindo intends to launch Dyrupeg™ in Europe in the second half of 2025 and is actively pursuing filings in additional markets. The company continues to enhance its biosimilars pipeline, demonstrating a commitment to increasing patient access to critical treatments for serious health conditions like cancer, presenting a positive outlook for growth in the biosimilars sector.