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Committed to Quality Worldwide

We are committed to the belief that everyone deserves access to safe, affordable medicines

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Mylan is proud to have launched Hertraz — the world’s first biosimilar trastuzumab

Supported by the expertise of Mylan, Hertraz meets the rigorous standards of biosimilar testing and approval.

Mylan Quality

Quality is in Our DNA

We follow one global quality standard across facilities and product lines, regardless of market

  • Significant investments in research and development in our globally integrated network that employs over 3,300 scientists and regulatory workforce members1
  • One of the world’s active pharmaceutical ingredient (API) manufacturers, with 80% of APIs manufactured internally
  • A vast network of 50 manufacturing facilities across the globe:
    • - 23 for oral solids
    • - 9 for injectables
    • - 9 for complex product sites
    • - 9 for APIs
  • Regular inspection of all our facilities by a range of health authorities such as FDA, TGA (Health Safety Regulation), and European Medicines Agency

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.

Biosimilars

What is a Biosimilar?

  • Biosimilars are biologic medicines that are highly similar to their reference biologics, as they have demonstrated no clinically meaningful differences in safety, purity, and potency compared to that of the reference biologics1
  • Biosimilar medicines may offer a less costly alternative to existing biological medicinal products

How do you Characterize a Biosimilar?

  • There are more than 20 physicochemical and 9 functional assays that are used to evaluate the similarity between HertrazTM and its reference medicine1,2
READ MORE

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.

About HertrazTM

HertrazTM, the World’s First Trastuzumab Biosimilar

Trastuzumab for injection, 150 mg/440 mg1

trastuzumab

What is trastuzumab?

Trastuzumab is a humanized monoclonal antibody that targets the HER2 protein.2

trastuzumab_work11

How does trastuzumab work?

Trastuzumab blocks the activity of the HER2 protein, which plays an important role in the control of cell growth.2

trastuzumab_work2

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:

  • 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. European Commission. Consensus Information Paper 2013: What You Need to Know About Biosimilar Medicinal Products. European Commission; 2013.
  • 3. Data on file.
Dosing

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

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  • Available in 440-mg and 150-mg multidose vials. Pack is accompanied with bacteriostatic WFI*1
  • Optimize the dose according to patient requirements and affordability2
  • Lower dosage can reduce financial burden on patients

Flexible Personalized Affordable Convenient

*WFI: Water for injection

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. European Commission. Consensus Information Paper 2013: What You Need to Know About Biosimilar Medicinal Products. European Commission; 2013.
Prescribing Information

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:

  • IHC2+ plus a confirmatory silver in situ hybridisation (SISH) or fluorescence in situ hybridisation (FISH) result, OR
  • IHC 3+ result
READ MORE
CLICK HERE FOR FULL PRESCRIBING INFORMATION
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