Latest news with #CuraTeQBiologicss.r.o.
The Hindu
13-05-2025
- Business
- The Hindu
Aurobindo Pharma arm's biosimilar gets marketing nod from U.K.'s MHRA
Aurobindo Pharma subsidiary CuraTeQ Biologics s.r.o. has received marketing authorisation for Zefylti, its filgrastim biosimilar version, from Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K. In February 2025, Zefylti had received the marketing authorisation in the European Union from the European Commission (EC). This is CuraTeQ's second biosimilar to be approved by MHRA. Bevqolva was the first in December 2024, Aurobindo Pharma said in a filing on Tuesday. In December, announcing receipt of positive opinion for Zefylti from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the company had said the product is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs).
Business Standard
26-04-2025
- Business
- Business Standard
CuraTeQ Biologics s.r.o. receives positive opinion for biosimilar Dazublys from EMA
Used for treatment of HER2-positive metastatic and early breast cancers CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers. Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on certain types of solid cancers such as breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its ability to signal, leading to cell cycle arrest, reduced tumor growth, and potentially immune system activation to destroy cancer cells. Aurobindo Pharma's Vice Chairman and Managing Director Mr. Nithyananda Reddy said, "The CHMP's positive opinion of a third biosimilar from our portfolio in a five-month time period underscores our extensive efforts in building biosimilars as one of the core businesses at Aurobindo. By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments, furthering our mission to serve patients with high-quality, cost-effective therapies."
Business Upturn
26-04-2025
- Business
- Business Upturn
Aurobindo Pharma subsidiary receives positive opinion for biosimilar Dazublys from EMA
By Aman Shukla Published on April 26, 2025, 09:57 IST CuraTeQ Biologics s.r.o., a subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Dazublys® (150 mg powder for concentrate for solution for infusion). Dazublys® is a biosimilar to trastuzumab, developed for the treatment of HER2-positive metastatic and early breast cancers. Trastuzumab, the active ingredient in Dazublys®, targets and inhibits the HER2 protein, which is over-expressed in certain cancers, particularly breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its signaling, leading to cell cycle arrest, reduced tumor growth, and activation of the immune system to attack cancer cells. The positive CHMP opinion is an important step for Dazublys® towards securing marketing authorization in the European Union. This approval would provide healthcare professionals with an effective, cost-effective alternative for treating HER2-positive breast cancer, potentially improving access to vital cancer therapies. CuraTeQ Biologics is committed to enhancing patient outcomes with biosimilar medicines, offering an affordable treatment option for cancer patients. The company remains focused on expanding its portfolio of biosimilars to address critical healthcare needs. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
