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Mylan and Biocon Get Approval for First Biosimilar to Herceptin for Certain Breast and Stomach Cancers

First FDA-approved biosimilar to Roche's $2 billion drug (Image: Policy and Medicine).

The FDA has approved the first biosimilar to Herceptin for all of its same indications, including the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer. The compound, called Ogivri, was developed in partnership by Mylan (Nasdaq: MYL) and Biocon of India, and is the first biosimilar product from the companies’ joint development portfolio.

An estimated 250,000 new cases of breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in the US in 2017. About 25% of primary breast cancers are HER2-positive. According to IQVIA (NYSE: IQV), Herceptin generated more than $2 billion in sales in the US for Roche (OTCQX: RHHBY) for the 12 months ending Sept. 30, 2017.

Biosimilar medicines fill an urgent and unmet need for more affordable alternatives to biologic therapies, increasing access and providing savings for patients and the overall healthcare system. It is projected that biosimilars will generate a savings of $54 billion in direct spending on biologic drugs in the U.S. between 2017 and 2026.

Source: Australia Department of Health

Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. According to the FDA, a biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product that’s already been approved and has no clinically meaningful differences in terms of safety, purity and potency from the reference product. The FDA Oncologic Drugs Advisory Committee had recommended approval of Ogivri in July 2017. The biosimilar drug is already approved in 19 countries including India and is under review by regulatory authorities in Australia, Canada, Europe and several additional markets.

The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients. We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.

– FDA Commissioner Scott Gottlieb, MD

The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the US healthcare system. It will allow us to bring this important biosimilar – the first of its kind – to market in the US, 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.

– Mylan CEO Heather Bresch

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