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(14 Dec 2024, 16:18)

Aurobindo Pharma arm receives positive opinion from EMA for Zefylti

Aurobindo Pharma has announced that its wholly owned subsidiary, CuraTeQ Biologics, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding its product Zefylti.


The CHMP has recommended the granting of marketing authorization for Zefylti, which is intended for the treatment of neutropenia and the mobilization of peripheral blood progenitor cells (PBPCs).

The company’s 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".

Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services.

The pharma major reported 7.95% rise in consolidated net profit to Rs 817.38 crore on a 6.93% increase in revenue from operations to Rs 7,646.21 crore in Q2 FY25 over Q2 FY24.

Shares of Aurobindo Pharma shed 0.59% to settle at Rs 1,207.95 on 13 December 2024.

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