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.

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*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.