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Results For "CuraTeQ-Biologics"

12 News Found

CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA
Drug Approval | April 28, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein


CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab
News | April 09, 2025

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


CuraTeQ Biologics receives approval for oncology biosimilar Bevqolva from UK's MHRA
News | December 22, 2024

CuraTeQ Biologics receives approval for oncology biosimilar Bevqolva from UK's MHRA

Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins


CuraTeQ Biologics receives positive opinion for biosimilar Zefylti
Drug Approval | December 14, 2024

CuraTeQ Biologics receives positive opinion for biosimilar Zefylti

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


CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'
News | January 17, 2024

CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'

Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer


EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility
Drug Approval | November 13, 2024

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections


Aurobindo's subsidiary to withdraw application for EU marketing authorization of two biosimilars
News | June 26, 2023

Aurobindo's subsidiary to withdraw application for EU marketing authorization of two biosimilars

This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA


Aurobindo Pharma to invest Rs 300 crore on mammalian cell culture manufacturing facility
News | September 02, 2022

Aurobindo Pharma to invest Rs 300 crore on mammalian cell culture manufacturing facility

The Board also decided that Auro Vaccines will explore the possibilities of offering contract manufacturing to global vaccine developers