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CuraTeQ Biologics receives positive opinion for biosimilar Zefylti



Posted On : 2024-12-13 19:55:22( TIMEZONE : IST )

CuraTeQ Biologics receives positive opinion for biosimilar Zefylti

CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (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 neutropenia and 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".

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1207.95 as compared to the previous close of Rs. 1215.15. The total number of shares traded during the day was 34151 in over 3682 trades.

The stock hit an intraday high of Rs. 1216.40 and intraday low of 1173.25. The net turnover during the day was Rs. 40734782.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 CuraTeQBiologics CHMP EMA PositiveOpinion Zefylti