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CuraTeQ Biologics Receives CHMP’s Positive Opinion for Dazublys (Biosimilar, Herceptin) 

Shots: 

  • CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EMA’s CHMP has granted a positive opinion to Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, to treat HER2-positive metastatic and early breast cancers. Pending expected EC approval in July, it will be available across the EU member states 
  • The opinion was based on its demonstrated similarity to Herceptin in PK, PD, efficacy, safety, and immunogenicity 
  • Trastuzumab targets and inhibits the HER2 protein, which is overexpressed in certain cancers like breast and gastric cancer 

Ref: CuraTeQ | Image: CuraTeQ

Related News:-  Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

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