At Mylan we always believed in bringing innovation’s to produce quality medicines and make therapy affordable with the aim of increasing access to medicines to many deserving patients.
We at Mylan India are excited and pleased to inform you that the U.S. Food and Drug Administration (FDA) has approved Mylan’s biosimilar trastuzumab in all indications as eligible for the reference product Herceptin.
Mylan’s trastuzumab in US is branded as Ogivri™. Ogivri™ is the first USFDA-approved biosimilar to Herceptin and the first biosimilar from Mylan in US. The FDA approval further demonstrates Mylan’s robust scientific capabilities in developing complex products.
The FDA approval was based on robust data from structural and functional characterization using multiple orthogonal techniques, nonclinical studies and pharmacokinetic evaluation in healthy subjects and patients and a safety, efficacy and immunogenicity study in relevant patient populations, which compared Mylan’s trastuzumab to Herceptin. The data demonstrated that Mylan’s trastuzumab is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. Earlier in July 2017, the ODAC committee concluded that “the totality of evidence supports a recommendation for FDA approval” and voted 16-0 in support of Mylan’s trastuzumab and recommended approval in all eligible indications of the reference product, Herceptin®, which include HER2-positive breast cancer in the metastatic and adjuvant settings.
Mylan is dedicated to supporting patients at every stage of cancer care with approximately 40 oncology supportive care, therapeutic and diagnostic products in the U.S. Mylan is a global leader in the development and manufacturing of complex products, including biosimilar medicines. Mylan’s robust portfolio of 16 biosimilar and insulin analog products, one of the largest and most diverse portfolio in the industry.
We at Mylan believe that this is a monumental achievement for Mylan to increase patient access to an affordable and quality trastuzumab to all eligible HER2 positive patients* and deliver significant savings to the healthcare system and more importantly to the patients.
We thank you sincerely for the faith bestowed on our product and supporting the cause of enhancing access to many more deserving cancer patients.
*Eligible HER2 positive patients refers to patients who fall into the category as mentioned in the indications of respective trastuzumab prescribing information and are eligible for treatment. Please refer to the full prescribing information for more details.
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.
How do you Characterize a Biosimilar?
|Primary Structure||Higher Order Structure||Post-Translation Modification||Product-Related Substances/Impurities||Biologic Activity|
|Amino acid sequence||Disulfide bridge||Glycoforms||High molecular weight protein||Fab, HER2 receptor binding|
|Intact mass||Secondary structure||Sialylation||Low molecular weight protein||Fab blockade|
|Tertiary structure||Aglycosylated, thioether-bridged fragments||Fc-gamma III receptor binding|
|Deamidation, charge variant|
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
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
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.
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:
HertrazTM 150 mg is reconstituted with 7.2 mL bacteriostatic water for injection (BWFI) and HertrazTM 440 mg should be reconstituted with 20 mL of BWFI. Reconstituted HertrazTM concentrate contains approximately 21 mg/mL of Trastuzumab. Calculate the volume of the 21 mg/mL reconstituted HertrazTM solution needed, withdraw this amount from the vial and add it to an infusion bag containing 250 mL of 0.9% Sodium Chloride Injection, USP. Do not use Dextrose (5%) solution.
Dosage and Administration
HertrazTM should be administered as intravenous infusion and not as an intravenous push or bolus. For HER2-positive positive breast cancer, administer at either initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly after beginning one week of initial dose, or initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 minutes IV infusion every three weeks after beginning three weeks of initial dose. For Metastatic Gastric Cancer (MGC), administer initial dose of 8 mg/kg, then 6 mg/kg every three weeks after beginning three weeks of initial dose.
Patients who are hypersensitive to Trastuzumab, murine proteins, or to any other component of HertrazTM or suffering from severe dyspnoea at rest due to complications of advanced malignancy, and are requiring supplementary oxygen therapy.
Trastuzumab for Injection (r-DNA Origin)
List of Excipients
TM Hertraz a white to pale yellow lyophilised powder.
Hertraz™ reconstituted with BWFI, as supplied, is stable for 28 days after reconstitution when stored refrigerated at 2°C-8°C (36ºF-46°F).
Manufactured in India by: