Biocon surgest 15% on USFDA approval

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Mylan has become the first pharma company to win United States approval for a biosimilar of Roche's big-selling cancer antibody Herceptin.

The US health regulator has approved Mylan NV's biosimilar Ogivri, co-developed with Biocon, for the treatment of certain breast and stomach cancers, a company statement said.

"The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the USA healthcare system", said Mylan's chief executive Mylan chief executive Heather Bresch.

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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). "This is especially important when it comes to diseases like cancer, that have a high cost burden for patients", Scott Gottlieb, FDA commissioner, said in an agency press release. "We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs".

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.

"It will allow us to bring this important biosimilar - the first of its kind - to market in the USA, expanding cancer-patient access to more affordable treatment". Dr Arun Chandavarkar, CEO & Joint MD, Biocon, added that the 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.

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In the USA, 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.

Annual sales of the Roche's cancer medicines - Rituxan, Herceptin and Avastin - top $21 billion, or more than half of its pharmaceuticals business, but are under threat as their biosimilar versions get approval.

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