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Mylan gets first biosimilar Herceptin OK from FDA

Ogivri approved by US regulators for all of Roche blockbuster's indications

Mylan

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

The biosimilar – developed by Mylan and Biocon and called Ogivri (trastuzumab-dkst) – has been approved by the FDA for HER2-positive breast or metastatic stomach cancer, the same indications as Herceptin which brought in almost $7bn in sales last year, around $2.5bn of that total from the US market.

Mylan said in a statement Ogivri is the first biosimilar in its collaboration with Biocon to get US approval, and while it has kept quiet about its commercialisation plans some analysts have suggested it will start making revenues from the drug in 2019 – the year in which Roche’s US patent on Herceptin expires.

Earlier this year Mylan and Roche agreed a licensing deal to avoid an expensive patent litigation process, with Mylan saying it had worked out a path to market for its drug and expected to be first to launch in the US, without saying exactly when that would occur.

This is the eighth biosimilar approved by the FDA in quick succession as the agency tries to take action on high drug prices in the US, and the second for a cancer antibody after Amgen and Allergan got a green light for their Mvasi biosimilar of Roche’s Avastin (bevacizumab) in September.

The agency’s commissioner, Scott Gottlieb, said that biosimilar approvals help “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”.

Gottlieb added that the FDA is “committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs”.

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.

"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,” remarked Mylan’s CEO Heather Bresch.

“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.”

Amgen/Allergan, Pfizer, and Samsung Bioepsis are also developing biosimilar Herceptin products for the US and international markets, but analysts have suggested that Roche’s brand will not see a dramatic reduction in sales after the rivals launch, in part because use of the drug in combination with newer HER2 drug Perjeta (pertuzumab) is on the rise.

Article by
Phil Taylor

4th December 2017

From: Regulatory

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