Zuhera Description

Zuhera is a white to pale yellow lyophilised powder.
Zuhera is a biosimilar of Herceptin.
Composition: 440 mg multi-dose vials containing powder for concentrate for solution for intravenous infusion. Reconstituted Zuhera concentrate contains approximately 21 mg/mL of trastuzumab, a humanised IgG1 monoclonal antibody expressed in Chinese hamster ovary cell suspension culture, and purified by affinity and ion-exchange chromatography including specific viral inactivation and removal procedures.
The 440 mg pack is provided with 20 mL bacteriostatic water for injection (containing 1.1% benzyl alcohol as preservative) for reconstitution.
In vitro, preclinical and clinical studies have demonstrated similarity between Zuhera and the reference trastuzumab product. Hence, this document includes publicly available information on the reference trastuzumab product. In this document, when data on the reference (originator) trastuzumab product is being referred to, the term "trastuzumab (Herceptin)" is used. The term "trastuzumab" is used to describe properties generally applicable to the trastuzumab molecule that are described based on observations with the reference product. Where information or instructions specific to Zuhera is presented, the term "Zuhera" is used.
Excipients/Inactive Ingredients: L-Histidine, L-Histidine hydrochloride, Polysorbate 20, Trehalose dihydrate.