FDA approves Mylan and Biocon’s Ogivri, the first biosimilar for trastuzumab in the USA

December 4, 2017 6:33 AM

Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), co-developed with Biocon.

Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S. Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year. This milestone secured a clear pathway to commercialize Mylan’s biosimilar to Herceptin in various markets globally.

Mylan CEO Heather Bresch commented: “The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system. It will allow us to bring this important biosimilar – the first of its kind – to market in the U.S., expanding cancer-patient access to more affordable treatment. As one of the nation’s leading suppliers of cancer medicines, Mylan is excited to add to our portfolio a product representing a new generation of targeted therapies that have radically changed the way the disease is treated. Ogivri is one of many biosimilars in our robust pipeline that we look forward to introducing in the coming years as part of our ongoing commitment to increasing access to important medicines for patients.”

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 Ogivri to Herceptin. The data demonstrated that Ogivri is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. The FDA’s decision follows the unanimous vote by the FDA Oncologic Drugs Advisory Committee (ODAC) in July 2017 recommending approval of Mylan’s biosimilar to Herceptin.

Mylan and Biocon’s biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in 19 countries around the world, including India, thus providing increased access to this more affordable biologic for cancer patients.

In the U.S., an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in 2017 alone. Approximately 20% to 25% of primary breast cancers are HER2-positive. Herceptin had U.S. sales of more than $2 billion for the 12 months ending Sept. 30, 2017, according to IQVIA.

 

 

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