Aurobindo Pharma Secures EC Approval for Marketing Zefylti

Aurobindo Pharma has announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for Zefylti, a filgrastim biosimilar, to CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of the Company.

Earlier in December 2024, the Committee for Medicinal Products (CHMP) of EuropeanMedicines Agency has adopted positive opinion recommending the approval of Zefylti.

Zefylti is intended for the treatment of neutropenia and the mobilization of peripheral progenitor cells (PBPCs).

Commenting on the update, the company spokesperson said, "After receiving the GMP certificate of compliance from the European Medicines Agency (EMA) in November, Zefylti is our first biosimilar to receive a positive opinion from EMA's CHMP. Two more products, our biosimilar versions of pegylated filgrastim (BP14) and trastuzumab (BP02), are currently under review with the EMA, and a biosimilar to bevacizumab (BP01) is under review with the MHRA. We are confident and on track to bring these treatment options to patients next year"

CuraTeQ Biologics Private Limited is a global biopharmaceutical company headquartered in Hyderabad, India. It is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ's pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substances to fill-finish and packaged drug products.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.

The company has 29 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.