FDA approves first biosimilar for treatment of certain breast, stomach cancers

FDA approves first biosimilar for treatment of certain breast, stomach cancers

FDA approves first biosimilar for treatment of certain breast, stomach cancers

Ogivri (trastuzumab-dkst) became the first biosimilar to Herceptin approved by the U.S. Food and Drug Administration (FDA) on December 1, and covers its use in all indications in the original treatment's label, including HER2-overexpressing breast cancer and metastatic stomach cancer. This milestone secured a clear pathway to commercialize Mylan's biosimilar to Herceptin in various markets globally, stated the company release.

The FDA said Mylan's Ogivri is the first biosimilar approved in the United States to treat breast cancer or stomach cancer and the second approved to treat cancer.

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Mylan N.V. (MYL) and Biocon Ltd. said that the U.S. Food and Drug Administration has approved Mylan's Ogivri or trastuzumab-dkst, a biosimilar to Herceptin or trastuzumab, co-developed with Biocon.

Scott Gottlieb, FDA Commissioner (MD, USA), concluded: "The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs".

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The FDA's decision was based on data showing the structural and functional similarities between Ogivri and Herceptin, in addition to preclinical and clinical trial data showing similar safety and effectiveness.

Mylan and Biocon already have approval for the Herceptin biosimilar in more than a dozen countries around the world, including India, and have also submitted their version for approval in Europe, Canada and Australia, among other markets. 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.

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"This approval represents a landmark achievement for the Biocon-Mylan collaboration and is an important endorsement of our development and manufacturing capabilities in the area of monoclonal antibodies", said Arun Chandavarkar, chief executive officer and joint managing director of Biocon.

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