Quality is in Our DNA
We follow one global quality standard across facilities and product lines, regardless of market
Mylan has received regulatory agency approval through current Good Manufacturing Practice (cGMP) regulations and stringent quality standards.1
Reference: 1. US Department of Health and Human Services, US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Washington, DC: US Department of Health and Human Services; 2015.
What is a Biosimilar?
How do you Characterize a Biosimilar?
References: 1. US Department of Health and Human Services, US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Washington, DC: US Department of Health and Human Services; 2015. 2. Data on file.
HertrazTM, the World’s First Trastuzumab Biosimilar
Trastuzumab for injection, 150 mg/440 mg1
What is trastuzumab?
Trastuzumab is a humanized monoclonal antibody that targets the HER2 protein.2
How does trastuzumab work?
Trastuzumab blocks the activity of the HER2 protein, which plays an important role in the control of cell growth.2
By targeting only cancerous cells, trastuzumab avoids harming healthy cells.2
A biosimilar and its reference medicine are expected to have the same safety and efficacy profile and are generally used to treat the same conditions.3
References:
Designed to Meet HER Needs
HertrazTM has 2 dosage options designed to fit patient needs – available in 440 mg and 150 mg.
HertrazTM offers flexible dosing
Flexible Personalized Affordable Convenient
*WFI: Water for injection
References:
Abridged Prescribing Information
HertrazTM Traztuzumab Injection 150 mg/440 mg
150 mg and 440 mg multi-dose vials contain lyophilised powder to be reconstituted for intravenous infusion.
Indications
Metastatic Breast Cancer (MBC)
HertrazTM is indicated for the treatment of metastatic breast cancer patients who have human epidermal growth factor receptor 2 (HER2)-overexpressing tumours.
Early Breast Cancer (EBC)
HertrazTM is indicated for the treatment of adult patients with HER2-positive early breast cancer.
HertrazTM should only be used in MBC or EBC patients who have tumours with either overexpression of HER2, or HER2 gene amplification.
Metastatic Gastric Cancer (MGC)
HertrazTM in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
HertrazTM should be used in only those MGC patients whose tumours overexpress HER2, as defined by: