Aurobindo Pharma arm gets positive opinion from EMA Committee for Zefylti for neutropenia treatment

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-12-14T12:30:01+05:30 | Updated On 14 Dec 2024 12:30 PM IST

Hyderabad: CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) within the European MedicinesAgency (EMA) has adopted a positive opinion for Zefylti (BP13, a filgrastim biosimilar) recommending the granting of a marketing authorisation.

Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropeniaand the mobilisation 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"

Read also: Aurobindo Pharma arm bags USFDA nod for cancer drug Pazopanib

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 substance to fillfinish 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.

curateq biologicsaurobindo pharmaaurobindo pharma newszefyltineutropeniapegylated filgrastimtrastuzumabbevacizumab

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751